2early Vs Late TracheotomyC

Early versus late tracheostomy for critically ill patients
(Review)
Gomes Silva BN, Andriolo RB, Saconato H, Atallah ÁN, Valente O
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2012, Issue 3
http://www.thecochranelibrary.com
Early versus late tracheostomy for critically ill patients (Review)

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Analysis 1.1. Comparison 1 Early versus late tracheostomy, Outcome 1 Mortality at maximal follow-up time available. 32
Analysis 1.2. Comparison 1 Early versus late tracheostomy, Outcome 2 Pneumonia. . . . . . . . . . . . . 33
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 43
Early versus late tracheostomy for critically ill patients (Review) i

[Intervention Review]
Brenda Nazaré Gomes Silva1 , Régis B Andriolo2 , Humberto Saconato3 , Álvaro N Atallah4 , Orsine Valente1
1 Brazilian
Cochrane Centre, Universidade Federal de São Paulo, São Paulo, Brazil. 2 Department of Public Health, Universidade do
Estado do Pará, Belém, Brazil. 3 Department of Medicine, Santa Casa de Campo Mourão, Campo Mourão, Brazil. 4 Brazilian Cochrane
Centre, Universidade Federal de São Paulo / Escola Paulista de Medicina, São Paulo, Brazil
Contact address: Brenda Nazaré Gomes Silva, Brazilian Cochrane Centre, Universidade Federal de São Paulo, Rua Pedro de Toledo,
598, Vl. Clementino, São Paulo, São Paulo, 04039-001, Brazil. brendagomess@gmail.com.
Editorial group: Cochrane Anaesthesia Group.

Publication status and date: New, published in Issue 3, 2012.
Review content assessed as up-to-date: 14 December 2010.
Citation: Gomes Silva BN, Andriolo RB, Saconato H, Atallah ÁN, Valente O. Early versus late tracheostomy for critically ill patients.
Cochrane Database of Systematic Reviews 2012, Issue 3. Art. No.: CD007271. DOI: 10.1002/14651858.CD007271.pub2.
ABSTRACT
Background
Long-term mechanical ventilation is the most common situation where tracheostomy is indicated for patients in intensive care units
(ICU). ’Early’ and ’late’ tracheostomies are two categories of the timing of tracheostomy. The evidence on the advantages attributed to
early over late tracheostomy is somewhat conflicting but includes shorter hospital stays and lower mortality rates.
Objectives
To evaluate the effectiveness and safety of early (≤ 10 days after intubation) versus late tracheostomy (> 10 days after intubation) in
critically ill adult patients predicted to be on prolonged mechanical ventilation and with different clinical conditions.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 12); MEDLINE (via
PubMed) (1966 to December 2010); EMBASE (via Ovid) (from 1974 to December 2010); LILACS (1986 to December 2010); PEDro
(Physiotherapy Evidence Database) at www.pedro.fhs.usyd.edu.au (1999 to December 2010) and CINAHL (1982 to December 2010).
Selection criteria
We included all randomized or quasi-randomized controlled trials which compared early tracheostomy (two to10 days after intubation)
against late tracheostomy (> 10 days after intubation) for critically ill adult patients expected to be on prolonged mechanical ventilation.
There was no language restriction.
Data collection and analysis
Two authors extracted data and conducted a quality assessment. Meta-analyses using the random-effects model were conducted for
mortality and pneumonia.
Main results
We included four studies, with a high risk of bias, in which a total of 673 patients were randomized to either early or late tracheostomy.
We could not pool data in a meta-analysis because of clinical, methodological and statistical heterogeneity between the included studies.
There is no strong evidence for real differences between early and late tracheostomy in the primary outcome of mortality. In one study
a statistically significant result favouring early tracheostomy was observed in the outcome measuring time spent on ventilatory support
(mean difference (MD) -9.80 days, 95% CI -11.48 to -8.12, P < 0.001).
Early versus late tracheostomy for critically ill patients (Review) 1
Authors’ conclusions
Updated evidence is of low quality, and potential differences between early and late tracheostomy need to be better investigated by
means of randomized controlled trials. At present there is no specific information about any subgroup or individual characteristics
potentially associated with better outcomes with either early or late tracheostomy.
PLAIN LANGUAGE SUMMARY

Timing of tracheostomy for critically ill patients who are predicted to be on long-term artificial respiration
Tracheostomy is a surgical procedure where an external artificial opening is made in the trachea (windpipe). Long-term mechanical
ventilation (where a machine is used to mechanically assist breathing) is the most common situation where tracheostomy is indicated for
patients in intensive care units (ICU). ’Early’ and ’late’ tracheostomies may be undertaken, categorised by the timing of tracheostomy.
We included four studies in this systematic review, with a total of 673 patients randomized to either an early or late tracheostomy. There
was no significant difference between early and late tracheostomies for patient deaths (mortality). The more significant effects of early
tracheostomy were the reduction in time spent on ventilatory support (by around nine days) and in the intensive unit care (by around
11 days), but even so the results were limited because they were observed in individual studies that had a high risk of bias (systematic
error) and a relatively low number of patients. There was no significant difference between the comparison groups with regards to
undesired events such as tracheal stenosis (narrowing of the trachea or windpipe) in hospital and sepsis (blood infection) because of
respiratory infection. Possible differences between early and late tracheostomy still need to be adequately investigated by means of
further randomized controlled trials. Moreover, there is no information about the best indication for either early or late tracheostomy
in patients with specific characteristics.

Early versus late tracheostomy for critically ill patients (Review) S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]
Early tracheostomy compared to late tracheostomy for critically ill patients
Patient or population: patients with critically ill patients

Settings:
Intervention: Early tracheostomy
Comparison: late tracheostomy
Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)
Assumed risk/mean dif- Corresponding risk

ference
Late tracheostomy Early tracheostomy
Mortality at maximal fol- 193/301 148/298 Not estimable 599 ⊕⊕

low-up time available (64.1%) (49.7%) (3 studies) low1,2,3,4,5,6,7
Follow-up: 1-12 months
Time spent on mechani- The mean time spent on The mean time spent on 120 ⊕⊕⊕
cal ventilation8 mechanical ventilation in mechanical ventilation in (1 study) moderate1,3,5,6,7,9,10
days the control groups was the intervention groups
Follow-up: 30-70 days 17.4 days8 was
9.8 lower
(8.12 to 11.48 lower)8
Pneumonia 59/270 33/269 Not estimable 539 ⊕⊕

Follow-up: 30 days (21.9%) (12.3%) (2 studies) low1,2,3,5,6,7,11
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;
3
Early versus late tracheostomy for critically ill patients (Review)
GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1 See ’Risk of bias’ table found in Characteristics of included studies section
2 Heterogeneity between studies was considered substantial, but all of individual estimate effects from primary studies had the same
direction which favoured the early tracheostomy group
3 All studies had compared early versus late tracheostomy for critically ill patients
4 There was appreciable but substantially heterogeneous estimate effects favouring early as compared to late tracheostomy
5 There was no reason to suspect of publication bias
6 Several clinical and methodological characteristics are suspected to change the estimate effects, including the type and severity of
baseline diseases, age range, methods available to perform the tracheostomy, etc. However, the effects of such factors could not yet be
precisely quantified. More studies are necessary.
7 The question of this systematic review about the effectiveness of early versus late tracheostomy for critically ill patients was based
on the potential association between earlier tracheostomy and lower probabilitIes of undesired but relevant outcomes such as death,
unsuccessful weaning from mechanical ventilation and pneumonia
8 No explanation was provided
9
Additional randomized controlled trials are necessary to either confirm or not the evidences available at the moment this review was
finished
10 The estimate effect was clinically relevant as showed by the MD of -9.80 days that favoured the early group and statistically significant
as showed by the 95% CI of -11.48 to -8.12 (P <0.00001)

11 The estimate effects were appreciable and had the same direction favouring the early tracheostomy group. However, the effects from
individual studies were substantially heterogeneous between each other (inconsistency test > 50%, P <0.10)
4
BACKGROUND
views about the best time for tracheostomy (Heffner 2003). Rel-
evant studies vary in design and the clinical condition (Ahmed
2007; Barquist 2006). To circumvent this the literature offers the
Description of the condition
two categories of ’early’ and ’late’ for the timing of tracheostomy.
Long-term mechanical ventilation is the most common situation Unfortunately these categories are not precisely defined and au-
where tracheostomy is indicated for patients in intensive care units thors use different times that they characterize as ’early’ and ’late’,
(ICU) (Heffner 2001). Although the definition of prolonged ven- which results in some overlap between the categories (Aissaoui
tilation can include periods as short as 24 hours (Criner 1994; 2007; Barquist 2006; Dunham 2006; Lesnik 1992). There is also
Griffiths 2005), only patients who are foreseen to be on artifi- conflicting evidence about the advantages of early over late tra-
cial ventilation for around 10 days or more (Armstrong 1998; cheostomies. For example, some comparative studies have shown
Plummer 1989) are generally subjected to elective tracheostomy. shorter hospital stays, lower mortality rates and other benefits with
In this circumstance, tracheostomy is offered as a strategy to re- the use of early tracheostomy as compared to late tracheostomy
duce respiratory injury and other undesired consequences of pro- (Arabi 2004; Rodriguez 1990). Conversely, Clec’h 2007 observed
longed translaryngeal intubation. These include ventilator-associ- no difference in mortality in ICU between patients with early and
ated pneumonia (Ranes 2006), sinusitis (Holzapfel 1993) and tra- late tracheostomies.
cheal stenosis (Cavaliere 2007). Some predictive systems have been
used to predict the duration of mechanical ventilation in various
patient settings (Agle 2006; Gajic 2007; Légaré 2001; Sellers 1997)
but many of these systems are not appropriately validated. Several How the intervention might work
other factors have also been shown to provide indications for tra- Potential benefits from tracheostomy include: lower airway resis-
cheostomy: neuromuscular disease or trauma, age, injury sever- tance, easier and safer tracheal suction, greater patient comfort,
ity score, damage control laparotomy, and others (Frutos-Vivar better communication, oral feeding, faster weaning from the venti-
2005; Goettler 2006). Other researchers propose that the decision lator and lower rates of ventilator-associated pneumonia (Heffner
to perform tracheostomy should be based on objective measures 2001; Plummer 1989). On the other hand, some of the disad-
from spontaneous breathing trials or weaning from mechanical vantages of tracheostomy include: dislodgement or obstruction,
ventilation trials (Freeman 2008). Thus, the development of pre- wound infection, scarring, a false passage, haemorrhage and sub-
dictive methods tailored for each clinical condition would be a glottic and tracheal stenosis (Bartels 1998; Dollner 2002; Higgins
major advance in patient care. 2007; Norwood 2000).
Description of the intervention Why it is important to do this review

Tracheostomy is a surgical procedure where an external, artifi- The present review intended to systematically map the evidence
cial opening is made in the trachea (Stedman 1995). A number on timing of tracheostomy (early versus late) in mechanically ven-
of techniques are used to perform tracheostomy. The main ones tilated, critically ill patients.
are the classical standard surgical procedure (in a surgical room)
and the percutaneous method performed at the patient’s bedside
(Friedman 2006; Gullo 2007; Pappas 2011; Schultz 2007). The
surgical and percutaneous procedures are usually performed by
different surgical specialists such as general, thoracic, ear, nose and OBJECTIVES
throat (ENT) or maxillofacial surgeons, while the percutaneous
To evaluate the effectiveness and safety of early (≤ 10 days af-
procedures are usually but not exclusively performed by surgeons
ter tracheal intubation) versus late tracheostomy (> 10 days after
and intensivists (Pappas 2011; Plummer 1989). There is also a
tracheal intubation) in critically ill adult patients predicted to be
diversity of materials (equipment and designs) used in performing
on prolonged mechanical ventilation and with different clinical
tracheostomy (Björling 2007; Crimlisk 2006; Hess 2005). These
conditions.
can potentially be associated with complications such as tracheal
ulceration, distortion of soft tracheal tissue and airway obstruction
(Tibballs 2006).
Plummer 1989 used the translaryngeal route for patients expected METHODS
to be on mechanical ventilation for up to 10 days and tracheostomy
for those on artificial ventilation for longer than 21 days; however,
tracheostomy is usually performed between the 10th and 14th day Criteria for considering studies for this review
of intubation (Armstrong 1998). Nowadays there are conflicting

Types of studies Secondary outcomes
We included all randomized or quasi-randomized controlled trials 1. Length of stay in ICU (or frequency of tracheostomy at any
(RCTs) published in any language. We included studies published time point)
in abstract form if sufficient information regarding their methods 2. Ventilator-associated pneumonia at any time point
and results were provided. We approached the principal authors 3. Laryngotracheal lesions at any time point (in epiglottis,
for additional information wherever necessary. vocal cord, larynx; subglottic ulceration and inflammation;
stenosis)
For details about definitions see Appendix 1 (Glossary of terms).
Types of participants
Search methods for identification of studies

Inclusion criteria
• Critically ill patients (for whom death is possible or
imminent) Electronic searches
• Patients expected to be on prolonged mechanical ventilation
We searched the following electronic databases: Cochrane Cen-
• Adults (≥ 18 years)
tral Register of Controlled Trials (CENTRAL) (The Cochrane
We defined prolonged mechanical ventilation as ventilation for Library 2010, Issue 12); MEDLINE (via the PUBMED inter-
from 24 hours to 21 consecutive days, six or more hours per day face) (1966 to December 2010); EMBASE (via Ovid interface)
(Divo 2010; Shirzad 2010). (from 1974 to December 2010); LILACS (1986 to Decem-
ber 2010); PEDro (Physiotherapy Evidence Database) at http://
www.pedro.fhs.usyd.edu.au) (1999 to December 2010) and CIN-
Exclusion criteria HAL (1982 to December 2010).
• Anatomical anomalies of the neck which would impair the The search strategy for MEDLINE included terms for clinical con-
tracheostomy procedure dition and intervention as well as their synonyms (see Appendix
• Patients already tracheostomized 2). This strategy was modified as required for other databases (see
• Coagulation disturbances (e.g., thrombocytopenia) Appendix 3 (CENTRAL); Appendix 4 (EMBASE); Appendix 5
• Soft tissue infection of neck (LILACS); Appendix 6 (Current Controlled trials) Appendix 7
(PEDro); and Appendix 8 (CINAHL). We used a highly sensitive
search filter for randomized controlled trials in databases where it
Types of interventions was necessary (MEDLINE, EMBASE and LILACS) to optimize
the search process (Higgins 2011b).
We considered the following comparison arms.
We did not impose any language restriction.
1. Early tracheostomy, if no serious attempt was made to wean
the patients from the ventilator (tracheostomy based only on
clinical or laboratory results, performed from two days to 10 Searching other resources
days after intubation).
We handsearched the references of relevant articles including nar-
2. Late tracheostomy, where weaning had not been successful,
rative reviews and non-randomized controlled studies in the area
performed later than 10 days after intubation.
of mechanical ventilation.
We searched for ongoing randomized controlled trials in the
Types of outcome measures Current Controlled Trials database at http://www.controlled-
trials.com/.
We considered all outcomes measures found in the primary studies.
For each outcome we accepted the definition used by the study
authors. We discussed, where necessary, limitations such as the
use of non-validated instruments for evaluation or a divergence of Data collection and analysis
definitions.
Selection of studies
Primary outcomes Two authors (HS and BGS) independently analysed the titles and
1. Mortality (time to mortality or frequency of deaths at any abstracts of publications obtained by the search strategy. We (RA
time point: in hospital, in ICU, or after discharge) and BGS) acquired all studies that met our inclusion criteria as
2. Duration of artificial ventilation full text.

Data extraction and management Dealing with missing data
We (RA and BGS) extracted data using a specially designed data Irrespective of the type of data, we planned to report dropout rates
extraction sheet (Appendix 9) containing information about meth- in the table Characteristics of included studies and perform in-
ods (study design), participants, interventions (for example sur- tention-to-treat (ITT) analysis only for dichotomous data (Deeks
gical procedures, materials) and results. We resolved all disagree- 2005).
ments by consensus. We contacted the authors of the primary
studies for further information about methodology and partici- Assessment of heterogeneity
pants, when necessary. Two authors (RA and BGS) abstracted the
data and entered all data into Review Manager (RevMan 5.1). A We presented data using a random-effects model (DerSimonian
third author (HS) rechecked all entries. 1986). We quantified inconsistency among the pooled estimates
using the Chi2 statistic, for heterogeneity we used the I2 statistic
(where I2 = [(Q - df )/Q] x 100%; Q is the Chi2 statistic and df
its degrees of freedom) . This illustrates the percentage of the vari-
Assessment of risk of bias in included studies ability in effect estimates resulting from heterogeneity rather than
Two authors (RA and BGS) assessed all included studies for from sampling error (Higgins 2002; Higgins 2003). We decided
methodological quality based on the criteria described in the not to combine the studies in a meta-analysis when they presented
Cochrane Handbook for Systematic Reviews of Interventions (Higgins substantial clinical and methodological heterogeneity in conjunc-
2011a). tion with statistical heterogeneity as indicated by the I2 statistic,
1. Was the random allocation sequence adequately generated? according to the following thresholds:
2. Was allocation adequately concealed? • 0% to 40%: may not be important;
3. Was knowledge of the allocated interventions adequately • 30% to 60%: may represent moderate heterogeneity;
prevented for data collectors, or they were independent from the • 50% to 90%: may represent substantial heterogeneity;
researchers who planned the study (blinding)? • 75% to 100%: considerable heterogeneity.
4. Were incomplete outcome data adequately addressed?
5. Are reports of the study free of suggestion of selective
Assessment of reporting biases
reporting?
6. Was the study apparently free of other bias? We planned to assess publication bias or a systematic difference
We classified each of the items as low risk of bias, high risk of bias between the smaller and larger studies (small study effects) by
or unclear risk of bias. preparing a funnel plot (trial effect versus trial size) if a sufficient
Because of the nature of the interventions of interest for this sys- number of studies were available (Copas 2000).
tematic review, we considered item 3 (blinding) only at the data
collection level. Data synthesis
We synthesized qualitative information relative to methods, risk of
bias, description of participants and outcomes measures and pre-
Measures of treatment effect sented them in the table ’Characteristics of included studies’. For
For comparable studies, dichotomous data were expressed as rela- quantitative data, we planned to use the random-effects model in
tive risk (RR) with 95% confidence intervals (CI) using the ran- the meta-analysis because of substantial clinical and methodologi-
dom-effects model (Deeks 2001a). We calculated number needed cal heterogeneity between studies, which by themselves could gen-
to treat (NNT) where risk differences were statistically significant erate substantial statistical heterogeneity. When data from primary
(Christensen 2006). For continuous data we calculated the mean studies were not parametric (for example effects were reported as
difference using the random-effects model. We planned to cal- medians, quartiles, etc) or were without sufficient statistical infor-
culate the standardized mean difference when the trials assessed mation (for example standard deviations, number of patients, etc)
the same outcome but used different instruments or scales (Deeks we planned to insert them into an ’Appendix’. Additionally, each
2001b). clinically relevant estimate effect was presented in a Summary of
findings for the main comparison (Schünemann 2009).
Unit of analysis issues Subgroup analysis and investigation of heterogeneity

We based the unit of analysis on the individual patient (unit to be We planned to stratify our analysis by the following independent
randomized for interventions to be compared) (Higgins 2011a). variables that are expected to be associated with heterogeneity.
We did not expect to find cross-over study designs because of the • By clinical condition (e.g., trauma, pre-existing
characteristics of the intervention. neurological and lung diseases).

• Different timing of ’early’ and ’late’ tracheostomies. be used for hypothesis generation to be tested in future adequately
• Type of tracheostomy, such as percutaneous or surgical designed studies.
tracheostomy.
We planned to only conduct these analyses if data were available

either in the report or by contacting the main authors of the studies.
In spite of the number of defined subgroup analyses, the eventual RESULTS
statistical heterogeneity observed across subgroups would not be
assumed to be a true causal relationship between dependent and
independent variables but only as generating a hypothesis to be Description of studies
tested in future trials. See: Characteristics of included studies; Characteristics of excluded
studies; Characteristics of ongoing studies.
Sensitivity analysis
If there were an adequate number of studies, we planned to per- Results of the search
form a sensitivity analysis to explore the causes of heterogeneity The search strategy retrieved 1433 citations across all electronic
and the robustness of the results. We planned to consider the fol- databases. We excluded duplicate references and thus retrieved
lowing factors in the sensitivity analysis: quality of allocation con- 1219 unique citations. Of these citations, we excluded a further
cealment (adequate or unclear or inadequate); blinding (adequate 1134, on the basis of title and abstract, because they were not
or unclear or inadequate or not performed); analysis using both specifically related to the ’timing of tracheostomy’. From the re-
random-effects or fixed-effect models; intention-to-treat analysis maining 85 studies, we excluded a further 74 because of their study
and available case analysis (only for dichotomous data), and stud- design. Thus, 11 studies had the potential to be included in the
ies with different times of early and late tracheostomies from our review (Figure 1). Of those 11 studies, we contacted the main au-
inclusion criteria. thors of one study for further information about the comparison
We did not plan to include the results obtained from subgroup and groups (Blot 2008). This study was later excluded for the reasons
sensitivity analyses as conclusions. We intended that they would outlined in the Characteristics of excluded studies.

Figure 1. Flow diagram showing the studies retrieved from databases to inclusion and exclusion.

At the title and abstract stage of selection, the Kappa coefficients
(Kc) to evaluate the concordances between the two observers (RA Excluded studies
and BNG) were calculated in the databases where there was at We excluded six studies because they compared early tracheostomy
least one discordance (Latour 1997). The concordance levels were with prolonged endotracheal intubation (Blot 2008; Bouderka
considered excellent for three databases: Kc = 0.91 (CENTRAL), 2004; El-Naggar 1976; Saffle 2002; Stauffer 1981; Sugerman
Kc = 0.85 (EMBASE), Kc = 0.94 (MEDLINE); and good for 1997). In one quasi-randomized study, the late tracheostomy was
CINAHL (Kc = 0.63). For the other databases there was no dis- performed eight days after admission (< 10 days) breaching the
cordance between the observers. selection criteria (> 10 days after intubation) for this review (
Rodriguez 1990). For further details, see the Characteristics of
Included studies excluded studies.
We included four studies available in English language journals

Risk of bias in included studies
(Barquist 2006; Dunham 1984; Rumbak 2004; Terragni 2010), We paid special attention to the description of randomization and
with a total of 673 patients randomized to either early or late allocation concealment, as the absence of adequate methodological
tracheostomy. The studies were diverse with respect to their in- aspects are associated with biased estimated effects (Schulz 1995).
clusion criteria, methods of tracheostomy and outcomes measures A synthesis of the assessment of all of the items of methodological
(see Characteristics of included studies). quality described below are presented in Figure 2 and Figure 3.
Figure 2. Risk of bias graph: review authors’ judgements about each risk of bias item presented as
percentages across all included studies.

Figure 3. Risk of bias summary: review authors’ judgements about each risk of bias item for each included
study.
Allocation
Rumbak 2004 did not explicitly report the method of randomiza-
tion; thus the study was considered to reflect a moderate risk of
bias.
Randomization
Two studies (Barquist 2006; Terragni 2010) reported computer-
generated randomization, which we considered to possess a low Allocation concealment
risk of bias. Neither study found significant differences between Two studies (Barquist 2006; Rumbak 2004) utilized envelopes to
the comparison groups in terms of baseline characteristics. conceal the allocation of participants. Terragni 2010 clearly re-
Dunham 1984 referred to randomization based upon the last digit ported a centralized process of randomization. These three stud-
of the patient’s hospital number, a method which we deemed in- ies were therefore considered to have a low risk of bias. However,
dicative of resulting in a high risk of bias (quasi-randomized study). Dunham 1984, a quasi-randomized study, was considered to pos-

sess a high risk of bias associated with the allocation concealment. Effects of interventions
See: Summary of findings for the main comparison Early
Blinding tracheostomy compared to late tracheostomy for critically ill
patients
In three studies (Barquist 2006; Dunham 1984; Rumbak 2004),
no information was given as to whether the data collectors were
independent from the researchers who designed the study, or were Primary outcomes
blinded to the allocations. These studies were thus considered to
have a moderate risk of bias associated with potential knowledge
about the allocated interventions (blinding). In contrast, Terragni Mortality
2010 clearly explained that a blinded clinician was responsible for
looking at the clinical charts remotely and for evaluating non- Mortality at day 28 of the follow-up was lower in the group sub-
objective components of the Clinical Pulmonary Infection Score. jected to early tracheostomy (26.3%, 55/209) as compared to the
Consequently, this study was deemed as possessing a low risk of late tracheostomy group (31.4%, 66/210), with a statistically non-
bias associated with the blinding. significant risk ratio (RR) of 0.84 (95% CI 0.62 to 1.13, P = 0.25)
in one study (Terragni 2010), see Table 1 (line 1). An ITT analysis
of combined mortality (at 28 days and at one year) showed 50%
Incomplete outcome data (127/209) for the early tracheostomy group and 70% (151/210)
Two studies (Barquist 2006; Rumbak 2004) were considered to for the late tracheostomy group (RR 0.85, 95% CI 0.74 to 0.97,
have a low risk of bias associated with incomplete outcome data, P = 0.02) (Terragni 2010), see Table 1 (line 2). Rumbak 2004 also
due to intention-to-treat (ITT) analysis and clear patient flow. reported a statistically significant result favouring the early tra-
Dunham 1984 was considered to possess a high risk of bias as, cheostomy (31.6%, 19/60) as compared to the late tracheostomy
after randomization, only those patients who were intubated for (61.6%, 37/60), with a risk ratio of 0.51 [0.34, 0.78, P = 0.002]
at least seven days were included in the study. The authors did not (Table 1, line 3). The direction of effect also favoured the early
indicate the percentages or number of patients not considered for tracheostomy in Barquist 2006 but without statistical significance
analysis after randomization (RR 0.43 [0.09, 2.03], P=0.29) (Table 1, line 4).
Terragni 2010 deserved special consideration because the authors After trying to combine the mortality rates (irrespective of follow-
reported ITT, but the numbers of patients from the randomization up time) in a meta-analysis, we found substantial heterogeneity
to the analysis of each outcome were not clearly reported for each between studies (Barquist 2006; Rumbak 2004; Terragni 2010) (I
2 = 66%, P < 0.10). Such a statistical heterogeneity is explained
one of the comparison groups. Therefore this study was considered
to have a high risk of bias. by the substantial clinical and methodological diversities between
the studies. Thus, data on mortality were presented in a forest
plot with isolated study estimated effects and no meta-analysis
Selective reporting (Analysis 1.1). The percentage of deaths in the early tracheostomy
Three studies were considered to have a low risk of bias based on group was 49.7% versus 64.1% in the late tracheostomy group.
the relevant outcomes considered for evaluation, and the absence
of suspected selective outcome reporting (Barquist 2006; Rumbak
Duration of artificial ventilation
2004; Terragni 2010). Dunham 1984 was deemed to be a study
with high risk of systematic error due to the absence of clinically Terragni 2010 measured the median values of ventilator-free days
relevant outcomes (such as mortality rates). at 28th day, which is considered a good outcome. The results
showed statistically significant (P = 0.02) estimated effects favour-
ing early tracheostomy (median 11 days, interquartile range 0 to
Other potential sources of bias 21 days) as compared to late tracheostomy (median 6 days, in-
Dunham 1984 evaluated 50% of the patients at four to six months terquartile range 0 to 17 days) (Appendix 10). Such non-paramet-
after extubation. The remaining patients were interviewed 12 ric data could not be reported as means and standard deviations
months after extubation but the exact number of patients per com- (SD). Thus, they were not appropriate for insertion in a forest
parison group was not specified. No indication was given of the plot. Rumbak 2004 reported a lower mean of days on mechanical
absence of substantial differences between the comparison groups ventilation in the early tracheostomy group (7.4 days, SD = 4)
at baseline (comparable groups). when compared with the late group (17.4 days, SD = 5.3), with a
Three studies were lacking clear information about the time of statistically significant mean difference (MD) of -9.80 (95% CI -
follow-up for all of the outcomes (Barquist 2006; Rumbak 2004; 11.48 to -8.12, P < 0.001) (Table 1, line 5). On the other hand,
Terragni 2010). Thus, none of these studies were considered to be Dunham 1984 reported the risk of artificial ventilation for more
free of other biases. than 21 days, with a higher proportion of events observed within

the early tracheostomy group (52.9%, 18/34) as compared to the at the study entry, than that observed in Rumbak 2004 (RR 0.20,
late tracheostomy group (45%, 18/40), but the estimated effect 95% CI 0.06 to 0.66, P = 0.008).
was not statistically significant (RR 0.85, 95% CI 0.53 to 1.36, P
= 0.49) (Table 1, line 6).
Terragni 2010 observed that 67.6% (142/210) of patients from Postoperative adverse events
the late tracheostomy group and 77% (161/209) from the early The different studies included in this systematic review found
group experienced a successful weaning. Thus, it was possible to no clinically or statistically relevant difference between early
estimate a statistically significant higher proportion of patients and late tracheostomies in the following postoperative adverse
with successful weaning in the early tracheostomy group as com- events: stoma inflammation; stoma infection; minor bleeding;
pared to the late tracheostomy group (RR 0.88, 95% CI 0.78 to major bleeding; pneumothorax; subcutaneous emphysema; tra-
0.99, P = 0.03, one study). The number of patients who needed to cheoesophageal fistula and cannula displacement or need for re-
be treated (NNT) in order to achieve just one successful weaning placement (Terragni 2010); significant laryngotracheal pathology;
was approximately 11 (95% CI 5.55 to 100) (Table 1, line 7). respiratory sepsis; major complications; complications (Dunham
1984); tracheal stenosis, irrespective of the severity (in hospi-
tal); tracheal stenosis > 50 (10 weeks postintubation) (Rumbak
Secondary outcomes
2004); and self extubation (Rumbak 2004). However, the follow-
ing events occurred significantly more in the early tracheostomy
Length of stay in ICU
group: tracheal stenosis with a severity score from 0 to 20 in hos-
pital and 10 weeks after intubation; tracheal stenosis, irrespective
Patients subjected to early tracheostomy seemed to have a higher
of the severity, 10 weeks after intubation (Rumbak 2004) (Table
probability of ICU discharge at 28 days after the randomization
1, line 10).
(48.3%, 101/209) as compared to the patients in the late tra-
cheostomy group ( 39%, 82/210), but the risk ratio was not sta-
tistically significant (RR 0.81, 95% CI 0.65 to 1.01, P = 0.06, one Other potentially relevant outcomes not planned in the
study) (Terragni 2010), see Table 1 (line 8). Moreover, Terragni protocol of this systematic review
2010 evaluated ICU-free days at 28 days after randomization, re-
No significant difference was found between comparison groups
sulting in an absence of difference in the median values between
related to the need for a long-term care facility; other outcomes
the comparison groups (median values of zero for both groups)
looked at were: days spent on sedation and on high dose vasopres-
(Appendix 10).
sor infusion, intraoperative adverse events and events followed by
In terms of the length of hospital stay, Terragni 2010 observed
death (Appendix 11).
no clinically relevant difference between groups, as shown by the
median values of 31 days (interquartile range 17 to 39) in the early
tracheostomy group and 32 days (interquartile range 18 to 59) in Sensitivity analysis
the late tracheostomy group (Appendix 10).
Clinically and statistically significant estimates favouring the early Because of the relative paucity of adequate studies, a sensitivity
tracheostomy group were observed for the time spent in the ICU analysis was not done.
(MD -11.40 days, 95% CI -12.42 to -10.38, P<0.00001) in one
study (Table 1, line 9).
DISCUSSION
Pneumonia
In the same way as for mortality, we tried to combine the pneu-
monia rates in a meta-analysis. We again found substantial het-
erogeneity between studies (Rumbak 2004; Terragni 2010) (I2 =
Summary of main results
0.73, P = 0.15). Such statistical heterogeneity was also justified Available evidence from randomized controlled trials showed no
because of the substantial clinical and methodological differences significant change in mortality at any time of follow-up in the
between studies. By consensus, we decided to present the data on early tracheostomy group as compared to the late tracheostomy
pneumonia in a forest plot with isolated estimated effects from group. Three trials (Barquist 2006; Rumbak 2004; Terragni 2010)
the studies, excluding a meta-analysis (Analysis 1.2). The percent- showed lower proportions of mortality at any time of follow-up in
age of events of pneumonia in the early tracheostomy group was the early tracheostomy group as compared to late tracheostomy,
12.3% versus 21.9% in the late tracheostomy group. The effect es- but this is not strong evidence.
timate was even weaker (RR 0.69, 95% CI 0.45 to 1.05, P = 0.08) Two observations from two different studies regarding the time
in Terragni 2010, which did not include patients with pneumonia spent on mechanical ventilation were also of importance. One

study indicated that early tracheostomy reduces the time on me- of realization, inclusion criteria, geographic region, and methods
chanical ventilation by more than nine days (9.8 days) (Rumbak of tracheostomy).
2004). The other study found more days ’free from the ventilator’, According to the Summary of findings for the main comparison
measured at day 28 of follow-up (Terragni 2010), in the early tra- the quality of the evidence was considered low for the outcomes of
cheostomy group. This study excluded patients with chronic ob- death and pneumonia, and moderate for successful weaning from
structive pulmonary disease, which is more likely to require long- mechanical ventilation.
term ventilation. Additionally, the same study (Terragni 2010)
demonstrates that early tracheostomy is significantly associated
with a higher rate of successful weaning. Potential biases in the review process
With respect to the secondary outcomes, the available evidence
from only one study involving more than 400 patients (Terragni A high sensitivity search strategy was used in this systematic review
2010) demonstrates that early tracheostomy is significantly associ- so as to avoid missing any randomized controlled trial that com-
ated with a higher rate of discharge from the ICU at day 28. Early pared early versus late tracheotomy in critically ill patients. We
tracheostomy again proved to be significantly superior to late tra- prevented any language bias by not imposing language restrictions
cheostomy in terms of the mean time spent in the ICU, but no upon the search.
differences were observed for ICU-free days at 28 days, the need Other studies have been conducted but were not yet published
for a long-term care facility or length of hospital stay (Terragni (Dumire 2008; Huttner 2010; Kluge 2009; Ranieri 2009; Young
2010). 2008) and their results may improve the evidence in this area.
There is no evidence to suggest that any one treatment is associated Thus, such ongoing studies will probably be included in future
with lower probability of pneumonia, possibly because of the large versions of this review once their results are made available.
heterogeneity between the studies (Rumbak 2004; Terragni 2010);
Terragni 2010 in fact excluded patients with chronic obstructive
pulmonary disease and pneumonia at study entry. Agreements and disagreements with other
studies or reviews
The findings of our systematic review and the reviews by Dunham
Overall completeness and applicability of 2006 and Griffiths 2005 do not support either early or late tra-
evidence cheostomy for mortality. Scales 2008, in a large observational
study involving more than 10,000 patients, showed that early
There is not sufficient evidence to recommend either early or late tracheostomy was associated with significant advantages in terms
tracheostomy in clinical practice since the findings of this system- of mortality over late tracheostomy for critically ill patients. Pre-
atic review did not demonstrate significant differences between the vious systematic reviews, as well as other observational studies
comparison groups measuring risk of mortality and pneumonia and non-randomized controlled trials with lower methodological
(Barquist 2006; Rumbak 2004; Terragni 2010). Although indi- rigour, also showed a decreased amount of time spent on ventila-
vidual studies (Rumbak 2004; Terragni 2010) favoured early tra- tory support (Arabi 2004; Arabi 2009; Blot 1995; Dunham 2006;
cheostomy compared to late tracheostomy in the time spent on Gandía-Martínez 2010; Griffiths 2005, Lesnik 1992; Zagli 2010);
mechanical ventilation, time in ICU and successful weaning, these time in the ICU (Arabi 2004; Arabi 2009, Gandía-Martínez
studies were judged to have high risk of bias. The same concern 2010; Griffiths 2005, Lesnik 1992; Zagli 2010), at the hospital
applies to Rumbak 2004, which suggested a higher risk of tracheal (Arabi 2004; Arabi 2009; Blot 1995); and lower probabilities of
stenosis in the early tracheostomy group. pneumonia (Lesnik 1992; Gandía-Martínez 2010) and extuba-
tion (El-Naggar 1976) with early tracheostomy as compared to
late tracheostomy. All these results have been observed in the face
of large clinical, regional, methodological and chronological di-
Quality of the evidence
versity among the studies.
Evidence in this review cannot be considered robust due to the low
number of studies (Barquist 2006; Dunham 1984; Rumbak 2004;
Terragni 2010) and the relatively low sample power for each of the
relevant outcomes (599 patients at most for mortality). Although
AUTHORS’ CONCLUSIONS
the estimated effects of studies with relevant outcomes (mortal-
ity and pneumonia) had the same direction, their intensities dif-
fered significantly, as demonstrated by heterogeneity tests. Such
Implications for practice
statistical heterogeneity probably resulted from the clinical and The evidence in this Cochrane review is insufficient to recommend
methodological diversity among the studies (for example, the date either early or late tracheostomy for critically ill patients. We have

insufficient information about any subgroup or individual charac- successful weaning, pneumonia and costs. All researchers inter-
teristic(s) potentially associated with the best indications for either ested in this research area should work together to unify the raw
early or late tracheostomy. data collected in their studies in order to make more information
available for inferences about more precise indications.
Implications for research

Additional high quality randomized controlled trials are neces-
ACKNOWLEDGEMENTS
sary to evaluate possible differences between early and late tra-
cheostomy for critically ill patients. Some trials have already be- We thank Dr Mathew Zacharias (content editor), Cathal Walsh
gun, and we are awaiting their results for an updated version of (statistical editor), Dr John Griffiths (peer reviewer), Dr John
this systematic review. Researchers would contribute significantly Heffner (peer reviewer), Dr Leila Bender (peer reviewer), Dr
to improving the evidence by considering the following outcome Bradley Freeman (peer reviewer) and Janet Wale (consumer) for
measures: mortality rates up to 12 months of follow-up, time spent their help and editorial advice during the preparation of this sys-
on mechanical ventilation and in the ICU, length of hospital stay, tematic review.
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∗
Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Barquist 2006
Methods Study design: parallel randomized controlled trial with intention-to-treat analysis and
sample size based in the following information: a total of 140 patients would be needed
if the SD was nine ventilator days, the difference between means was three days and the
power was set at 90%
Local/Setting: Division of Trauma and Surgical Critical Care, DeWitt Daughtry Family
Department of Surgery, University of Miami School of Medicine, Miami, Florida
Participants • N=60 (early tracheostomy, n = 29 / late tracheostomy, n = 31)

• Age range:18-87 / mean age: 51.8 (whole sample)
• Gender: 46 male / 14 female
• Ventilator dependent patients
• Traumatic injury as the proximate cause of their ventilator dependence
• Intubated at least 3 days when they were seven days after admission to the Trauma
ICU
Interventions 1. Early tracheostomy: before day 8

2. Late tracheostomy: after day 28
All tracheostomies (early and late) were performed by the open surgical technique
Outcomes • Mortality rates (time of data collection was not explicitly referred by the authors)
• Mean ICU free days at 20 days:
• Mean Ventilation free at day 30 (with extubation performed after spontaneous
breathing trial [CPAP at 5 cm water pressure with 5 cm water pressure support for 30
minutes] with predefined criteria for passing [pO2 greater than 55 mm Hg, respiratory
rate less than 35 breaths/minute and no respiratory acidosis)]
• Mean ICU free at day 30
• Ventilator-associated pneumonia at any time point (CDC CRITERIA: Centers
for Disease Control: elevated WBC, fevers, CXR infiltrate, and Broncho-Alveolar
Lavage [BAL] culture with greater than 10,000 colony-forming units per millilitre
[CFU/mL])
• Single superficial surgical site infection
• Major complications related to the tracheostomy (including stomal infection,
stomal haemorrhage, major vascular injury, pneumothorax, subglottic stenosis, and
tracheo-oesophageal fistulae)
Notes Four patients in the ’late’ group had a surgical tracheostomy placed on days 17, 18, 19,
and 21 to facilitate transfer to long-term care
Method to predict prolonged artificial ventilation: Not explicitly reported
Risk of bias
Bias Authors’ judgement Support for judgement

Barquist 2006 (Continued)
Random sequence generation (selection Low risk Computer-generated table

bias) The authors referred no significant differ-
ence between comparison groups on base-
line characteristics
Allocation concealment (selection bias) Low risk After consent was obtained, an envelope
with the assigned group inside was opened
Blinding (performance bias and detection Unclear risk There was no information on whether
bias) data collectors were independent from the
All outcomes researchers who designed the study or
blinded to the allocations
Incomplete outcome data (attrition bias) Low risk The authors carried out the intention-to-
All outcomes treat analysis according to the appropriated
definition
Selective reporting (reporting bias) Low risk No suspected selective outcome reporting,
since relevant outcomes were evaluated
Other bias High risk Although times of follow-up were explicitly

announced for only three outcomes (mean
ICU free days at 20 days, mean ventilation
free at day 30, mean ICU free at day 30),
the authors were not explicit to report the
follow-up times for the other outcome data
Dunham 1984
Methods Study design: Parallel quasi-randomized controlled trial without intention-to-treat anal-
ysis
Local/Setting: The Shock Trauma Center of the Maryland Institute for Emergency Med-
ical Services Systems (MIEMSS)
Participants • N=74 (Early tracheostomy, n = 34 / Late tracheotomy, n = 40)

• Age range: 17 to 75 years
• Intubation for at least 7 days
• Severe head injury
• Respiratory insufficiency and/or a tenuous or incompetent airway secondary to
maxillofacial injury
Interventions 1. The early group underwent transtracheal intubation at three to four days after
initiation of translaryngeal intubation
2. Patients assigned to the late group had transtracheal intubation performed 14 days
after the initiation of translaryngeal intubation, if continued intubation was required.
Trachestomy (early and late) method: the incision was standardized as a vertical soft
tissue incision and a vertical incision through the second and third tracheal rings and
the upper half of the fourth ring without removing any tracheal tissue

Dunham 1984 (Continued)
Outcomes • Significant laryngotracheal pathology (irrespective of type) that required surgery

and/or prolonged tracheal intubation beyond that required for the patient’s general
condition
• Respiratory sepsis (tracheitis, pneumonia, lung abscess, and peristomal infection)
• Major complications (not explicitly defined by the authors)
• Complications (self-extubation, patient tolerance, respiratory hygiene, and
aspiration)
• Proportion of patients intubated for until 21 days
Notes Method to predict prolonged artificial ventilation: patients were randomized into an early
or late tracheostomy group If at the end of 48 to 72 hours of translaryngeal intubation
the attending surgeon felt that a patient needed at least 48 hours of additional tracheal
intubation
Gender: Not informed
Risk of bias
Random sequence generation (selection High risk Randomization was based on the last digit
bias) of the patient’s hospital number; even
numbers comprised the early tracheostomy
group and odd numbers comprised the late
tracheostomy group
There were substantial differences of fre-
quency of baseline characteristics between
comparison groups (rigid head injury, non-
head injury and non-rigid, head injury)
Allocation concealment (selection bias) High risk The method of sequence generation used
in this study ideally permits anyone to fore-
see the group by which each one of the par-
ticipants would be allocated
Incomplete outcome data (attrition bias) High risk After randomization, only patients who
All outcomes were intubated for at least seven days were
included. The authors did not inform per-
centages or number of patients not consid-
ered for analysis after randomization
Selective reporting (reporting bias) High risk Authors did not reported mortality

Dunham 1984 (Continued)
Other bias High risk Fifty per cent of the patients were evalu-
ated at four to six months after extubation;
the remaining patients were interviewed 12
months after extubation and there was no
indication about the number of patients by
each one of the comparison groups
Statistical differences at baseline not in-
formed. No explicit information about the
times of follow-up
Rumbak 2004
Methods Study design: Parallel randomized controlled trial without intention-to-treat analysis
Local/Setting: Medical Intensive Units at the Baptist Memorial Hospital, University
of Tennessee, Memphis, TN, and Tampa General and the James A. Haley Veterans
Administration Hospital, University of South Florida, Tampa, FL
Participants • N: 120 (Early tracheostomy, n = 60 / Late tracheostomy, n = 60)

• Mean age: 63 years
• Projected to need ventilation support for >14 days
• initial Acute Physiology and Chronic Health Evaluation (APACHE) II score > 25
Interventions 1. Tracheotomy within 48 hours after intubation

2. Late tracheotomy at days 14 to16
Patients from both groups were subjected to percutaneous Dilational Tracheotomy Pro-
cedure
Outcomes • Mortality
• Mean intensive care stay:
• Days mechanically ventilated:
• Days sedated
• Days on high-dose pressors
• Pneumonia
• Ventilator-associated pneumonia and death
• Gastrointestinal bleed and death
• Acute myocardial infarction and death
• Pulmonary embolus and death
• Intractable septic shock and death
• Withdrawal of life support and death
• Respiratory failure and death
• Tracheal stenosis 0-20 (in-hospital)
• Tracheal stenosis 21-50 (in-hospital)
• Tracheal stenosis >50 (in-hospital)
• Tracheal stenosis 0-20 (10-wk postintubation)
• Tracheal stenosis 21-50 (10-wk postintubation)
• Tracheal stenosis >50 (10-wk postintubation)
• Self-extubation

Rumbak 2004 (Continued)
Notes Method to predict prolonged artificial ventilation: Not explicitly reported
Risk of bias
Random sequence generation (selection Unclear risk Not explicitly reported.

bias) The groups were similar in mean age, pro-
portion of women and African Americans,
APACHE II score, and underlying diseases
Allocation concealment (selection bias) Low risk Independent group randomization was
placed in sequentially numbered envelopes
to be open once consent was signed
Incomplete outcome data (attrition bias) Low risk Although there was no intention-to-treat
All outcomes analysis, the patients flow within the study
was clear
Selective reporting (reporting bias) Low risk Clinically relevant outcomes were reported
by the authors.
Other bias High risk The authors (except SWS) performed the
percutaneous dilational tracheotomy
Although, the airways were assessed for
oral, laryngeal, and tracheal damage at 10
weeks postintubation, there is no explicit
information about time of follow-up for the
other outcomes
Terragni 2010
Methods Study design: Parallel randomized controlled trial with intention-to-treat analysis
Local/Setting: Italian Intensive Care Units
Participants • N= 419 (Early tracheostomy, n = 209 / Late tracheostomy, n = 210)

• Mean age: 61.5 years old
• Mechanically ventilated for acute respiratory failure for 24 hours;
• Simplified Acute Physiology Score II between 35 and 65;
• Sequential organ failure assessment (SOFA) score > 5;
• Without a pulmonary infection (estimated by a Clinical Pulmonary Infection
Score [CPIS] of <6), chronic obstructive pulmonary disease, anatomical deformity of

Terragni 2010 (Continued)
the neck (including thyromegaly) and cervical tumors; a history of oesophageal,

tracheal, or pulmonary cancer; previous tracheotomy; soft tissue infection of the neck;
hematological malignancy; or pregnant
• PaO2 ≤ 60 mm Hg
• Fraction of inspired oxygen (FIO2 ) ≥0.5
• Positive end-expiratory pressure (PEEP) ≥8 cm H2 O
• Acute clinical condition requiring ventilatory support and still unresolved
• SOFA score ≥5
Interventions 1. Early tracheostomy: After six to eight days of laryngeal intubation

2. Late tracheostomy: after 13 to15 days of laryngeal intubation
Patients from both groups were subjected to percutaneous tracheostomy
Outcomes • Mortality (28 days)

• Mortality (at one year)
• Need for a long-term care facility
• Ventilator-free days (at day 28)
• ICU-free days (at day 28)
• ICU discharge
• Successful weaning
• Hospital length of stay
• Ventilator associated pneumonia
• Intraoperative adverse events (minor bleeding, significant bleeding, tube
dislocation, hypoxaemia, arrhythmia, cardiac arrest)
• Postoperative adverse events (stoma inflammation, stoma infection, minor
bleeding, major bleeding, pneumothorax, subcutaneous emphysema,
tracheoesophageal fistula, cannula displacement or need for replacement)
Notes Method to predict prolonged artificial ventilation: mechanically ventilated for acute
respiratory failure for 24 hours; Simplified Acute Physiology Score II between 35 and
65; sequential organ failure assessment (SOFA) score ≥ 5
Risk of bias
Random sequence generation (selection Low risk Computer-generated randomization

bias) schedule.
Baseline characteristics at admission or be-
fore randomization did not differ between
the two groups
Allocation concealment (selection bias) Low risk Randomization conducted centrally us-
ing a computer generated randomization
schedule
Blinding (performance bias and detection Low risk According to the authors, ”a clinician
bias) blinded to patient allocation looked at the
All outcomes clinical charts remotely and evaluated the

Terragni 2010 (Continued)
nonobjective components of the CPIS (qual-

ity of secretions, chest x-ray, evidence of acute
respiratory distress syndrome)”.
Incomplete outcome data (attrition bias) High risk Intention-to-treat analysis (ITT) was an-
All outcomes nounced by the authors, but the exact
method was not clearly reported. The num-
bers of patients from the randomization to
the analysis of each outcomes were not co-
herent. The authors of this systematic re-
view could not perform the most accepted
ITT analysis performed by imputing the
undesired outcome for all patients who
dropped-out and/or for those who with-
drawn from the planned protocol
The addition of the number of patients
who died at 28 days and one year (reported
in the article) plus the number of with-
drawals from protocol exceeds the number
of randomized patients. Similarly, the addi-
tion of all explicitly reported deaths at the
28 days and at one year of follow-up plus
the difference between the total of random-
ized participants minus the number of par-
ticipants “who left the hospital alive” is in-
compatible with the total number of ran-
domized participants
The difference between the total of ran-
domized patients minus the number of par-
ticipants “who left the hospital alive” is in-
coherent with the number of death at 28
days
Selective reporting (reporting bias) Low risk None suspected. Clinically relevant out-
comes were analysed.
Other bias High risk There was no explicit information about

the time of follow-up for some postop-
erative adverse events: stoma inflamma-
tion, stoma infection, minor bleeding, ma-
jor bleeding, pneumothorax, subcutaneous
emphysema, tracheoesophageal fistula)

Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Blot 2008 Early tracheotomy versus prolonged endotracheal intubation. No data available for patients subjected to the late
tracheostomy
Bouderka 2004 Early tracheostomy versus prolonged endotracheal intubation.
El-Naggar 1976 Early tracheostomy versus prolonged endotracheal intubation.
Rodriguez 1990 Late tracheostomy >8 days after admission (before 10 days).
Saffle 2002 Early tracheostomy versus continued endotracheal intubation with no data available specifically for patients sub-
jected to the late tracheostomy
Stauffer 1981 Early tracheostomy versus continued endotracheal intubation.
Sugerman 1997 Early tracheostomy versus continued endotracheal intubation with no data available for patients subjected to the
late tracheostomy
Characteristics of ongoing studies [ordered by study ID]
Dumire 2008
Trial name or title A prospective, randomized trial of early versus conventional conversion from endotracheal intubation to
percutaneous tTracheostomy for ventilatory support of trauma patients with severe brain injury
Methods Open label parallel randomized controlled trial
Participants - 18 years of age or older
- TBI defined as penetrating or blunt brain injury including

1. subarachnoid haemorrhage
2. subdural haemorrhage
3. epidural haemorrhage
4. brain contusion
5. diffuse axonal injury
- mechanically ventilated by endotracheal intubation
- projected to need ventilation support for more than 14 days according to: GCS measured in field less than
or equal to eight and a GCS on day three which remains less than or equal to eight
- informed consent obtained from patient or legal representative
Interventions 1. Early tracheostomy (less than or equal to 72 hours)

2. Late tracheostomy (10 to 14 days).

Dumire 2008 (Continued)
Outcomes • Total number of mechanical ventilation days until discharged

• Total number of hospital days until discharged
• Incidence of ventilator-associated pneumonia until discharged
• Incidence of accidental extubation until discharged
• Incidence of death until discharged
Starting date February 2006
Contact information Pennsylvania, United States

Memorial Medical Center
Johnstown
Pennsylvania
15905
Notes
Huttner 2010
Trial name or title WEANING-Study: “Weaning by early versus late tracheostomy in supratentorIal intracerebral bleedings”
Participants - Patients requiring intubation/mechanical ventilation
- Supratentorial intracerebral haemorrhage (including:)
- primary spontaneous ICH (lobar/deep)
- ICH related to anticoagulant therapy
- with or without intraventricular haemorrhage
- with or without occlusive and/or communicating hydrocephalus
- Haematoma volume > 0 ml and < 60 ml
- Age 18 - 85 years
- Informed consent (legal representative)
Interventions “Early” tracheostomy within 72 hours after hospital admission

“Late” tracheostomy (= control group; undergoing conventional tracheostomy between day 12 to14 if extu-
bation fails). Both groups receive plastic tracheostomy
Outcomes • Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care 30 days
• Incidence of respirator-associated pneumonia 30 days
• Cumulative consumption of sedative drugs 30 days
• Incidence of episodes with increased intracranial pressure 30 days

Huttner 2010 (Continued)
• In-hospital mortality 30 days

• Three-months functional outcome (mRS) 90 days No functional outcome after three months using
the modified Rankin Scale
Starting date July 2010
Contact information Hagen B. Huttner, MD

tel: +4991318544523
hagen.huttner@uk-erlangen.de
Notes
Kluge 2009
Trial name or title Early versus late percutaneous dilation tracheostomy in mechanically ventilated patients with chronic ob-
structive pulmonary disease
Participants - >18 years old

- Diagnosis of COPD (GOLD stage III or IV)
- Suspected long-time invasive mechanical ventilation due to ARF (> 10 days)
- Informed consent of the patient or legal guardian
Interventions Early tracheostomy: tracheostomy at the next possible opportunity but not later than 72 h after initiation of
invasive ventilation
Patients of the control group will be invasively ventilated at least until Day 10
Outcomes • Cumulative duration of mechanical ventilation (in days) Day 1 to 28

• All-cause mortality Day 28, 90 and end of ICU stay
• Length of stay on ICU / hospital end of ICU / hospital stay
• Infections (ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious
complications) Day 1 to28
• Cumulative use of sedatives Day 1 to 28
• Quality of Life discharge from ICU, day 28 and day 90
Starting date October 2009
Contact information Stefan Kluge, MD

tel: +4940 7410 ext.: 57010
s.kluge@uke.de
Notes

Ranieri 2009
Trial name or title Efficacy of early tracheostomy to reduce incidence of ventilator acquired pneumonia (VAP)
Participants - Oro/nasotracheal intubation for less than three days

- Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to
Intensive Care Unit (ICU)
Interventions Early tracheostomy on day three to five

Late tracheostomy on days 10-12
Outcomes • Increase of “ventilator associated pneumonia-free days”. Follow-up terminates on day 28 from the date
of oro/nasotracheal intubation
• Increase of “ventilator-free days”. Follow-up terminates on day 28 from the date of oro/nasotracheal
intubation
• Reduction of mortality one year
Starting date June 2004
Contact information Italy

University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin
10126
Notes
Young 2008
Trial name or title Tracheostomy Management in Critical Care
Methods Randomized controlled trial
Participants Eligible patients:

a. Are intubated
b. High chance of requiring a further seven days or more of ventilatory support during their ICU stay
c. Have been in the intensive care unit for less than four days
d. The recruiting consultant is uncertain about whether an ’early’ or ’late’ tracheostomy is more appropriate
for this patient
Interventions Group 1: ’Early tracheostomy’

Tracheostomy on day one to four post ICU admission
Group 2: ’Late tracheostomy’
No tracheostomy before day 10 post ICU admission
Outcomes • Mortality 30 days after randomisation.

• Mortality rate at discharge from hospital
• ICU length of stay
• Hospital length of stay (acute hospitals)
• Mortality rate at (first) discharge from ICU
Young 2008 (Continued)
• Number of days receiving any sedative medication

• Number of antibiotic-free days
Starting date 01/10/2004
Contact information c/o Lesley Morgan

Kadoorie Centre for Critical Care Research and Education
Level 3
John Radcliffe Hospital
Oxford
United Kingdom
OX3 9DU
Notes

DATA AND ANALYSES
Comparison 1. Early versus late tracheostomy
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Mortality at maximal follow-up 3 Risk Ratio (M-H, Random, 95% CI) Totals not selected
time available
2 Pneumonia 2 Risk Ratio (M-H, Random, 95% CI) Totals not selected
Analysis 1.1. Comparison 1 Early versus late tracheostomy, Outcome 1 Mortality at maximal follow-up
time available.
Review: Early versus late tracheostomy for critically ill patients
Comparison: 1 Early versus late tracheostomy
Outcome: 1 Mortality at maximal follow-up time available
Study or subgroup Early tracheostomy Late tracheostomy Risk Ratio Risk Ratio
M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
Barquist 2006 2/29 5/31 0.43 [ 0.09, 2.03 ]
Rumbak 2004 19/60 37/60 0.51 [ 0.34, 0.78 ]
Terragni 2010 127/209 151/210 0.85 [ 0.74, 0.97 ]
0.1 0.2 0.5 1 2 5 10

Favours early trach Favours late trach

Analysis 1.2. Comparison 1 Early versus late tracheostomy, Outcome 2 Pneumonia.
Review: Early versus late tracheostomy for critically ill patients
Comparison: 1 Early versus late tracheostomy
Outcome: 2 Pneumonia
Study or subgroup Early tracheostomy Late tracheostomy Risk Ratio Risk Ratio
M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
Rumbak 2004 3/60 15/60 0.20 [ 0.06, 0.66 ]
Terragni 2010 30/209 44/210 0.69 [ 0.45, 1.05 ]
0.01 0.1 1 10 100

Favours early trach Favours late trach
ADDITIONAL TABLES
Table 1. Continuous and dichotomous outcomes not possible to be combined in a meta-analysis
Outcome n Estimate effect (MD or RR, Favoured group Study

95% CI, P, NNT, CI 95% for
NNT)
1. Mortality at 28 days 419 RR 0.84 [0.62, 1.13, P = 0.25] Early tracheostomy Terragni 2010
2. ITT analysis of com- 419 RR 0.85 [0.74, 0.97, P = 0.02] Early tracheostomy Terragni 2010
bined mortality (at 28
days and at one year)
3. Mortality (in hospital- 60 RR 0.51 [0.34, 0.78, P = 0.002] Early tracheostomy Rumbak 2004
30 days)
4. Mortality (in hospital) 120 RR 0.43 [0.09, 2.03, P = 0.29] Early tracheostomy Barquist 2006
5. 120 MD -9.80 [-11.48, -8.12, P<0. Early tracheostomy Rumbak 2004

Time spent on mechani- 001]
cal ventilation (days)
6. Intubation for more 74 RR 0.85 [0.53, 1.36, P = 0.49] Late tracheostomy Dunham 1984
than 21 days
7. Successful weaning 419 RR 0.88 [0.78, 0.99, P = 0.03, Early tracheostomy Terragni 2010
NNT=11]
8. ICU discharge at day 419 RR 0.81 [0.65, 1.01, P = 0.06, Early tracheostomy Terragni 2010
28 NNT =11]

Table 1. Continuous and dichotomous outcomes not possible to be combined in a meta-analysis (Continued)
9. Time spent on ICU 120 -11.40 [-12.42, -10.38, P<0. Early tracheostomy Rumbak 2004
(days) 001]
10. Postoperative adverse events
10.1 Stoma inflamma- 264 RR 1.00 [0.57, 1.78, P = 0.99] Late tracheostomy Terragni 2010
tion
10.2 Stoma infection 264 RR 1.06 [0.41, 2.75, P = 0.91] Late tracheostomy Terragni 2010
10.3 Minor bleeding 264 RR 1.09 [0.39, 3.07, P = 0.86] Late tracheostomy Terragni 2010
10.4 Major bleeding 264 RR 0.82 [0.17, 3.99, P = 0.81] Early tracheostomy Terragni 2010
10.5 Pneumothorax 264 RR 2.47 [0.10, 59.98, P = 0.58] Late tracheostomy Terragni 2010
10.6 Subcutaneous em- 264 RR 2.47 [0.10, 59.98, P = 0.58] Late tracheostomy Terragni 2010
physema
10.7 Tracheoesophageal 264 RR 2.47 [0.10, 59.98, P = 0.58] Late tracheostomy Terragni 2010
fistula
10.8 Cannula displace- 264 RR 4.11 [0.20, 84.78, P=0.36] Late tracheostomy Terragni 2010
ment or need for replace-
ment
10.9 Significant laryngo- 74 RR 1.41 [0.47, 4.22, P=0.54] Late tracheostomy Dunham 1984
tracheal pathology
10.10 Respiratory sepsis 74 RR 1.18 [0.77, 1.79, P=0.45] Late tracheostomy Dunham 1984
10.11 Major complica- 74 RR 1.41 [0.47, 4.22, P=0.54] Late tracheostomy Dunham 1984
tions
10.12 Complications 74 RR 1.41 [0.47, 4.22, P=0.54] Late tracheostomy Dunham 1984
10.13 Tracheal stenosis 120 RR 1.27 [1.04, 1.55, P = 0.02, Late tracheostomy Rumbak 2004
0-20 (in hospital) NNT=10]
10.14 Tracheal stenosis 120 RR 0.50 [0.20, 1.25, P = 0.14] Early tracheostomy Rumbak 2004
21-50 (in hospital)
10.15 Tracheal stenosis 120 RR 0.40 [0.08, 1.98, P = 0.26] Early tracheostomy Rumbak 2004
>50 (in hospital)
10.16 Tracheal stenosis 120 RR 1.03 [0.98, 1.09, P = 0.24] Late tracheostomy Rumbak 2004
irrespective of the sever-
ity (in hospital)

Table 1. Continuous and dichotomous outcomes not possible to be combined in a meta-analysis (Continued)
0-20 (10-wk postintuba- NNT = 4.54]
tion)
21-50 (10-wk postintu-
bation)
>50 (10-wk postintuba-
tion)
irrespective of the sever- NNT = 3.33]
ity (10-wk postintuba-
tion)
10.21 Self-extubation 120 RR 0.08 [0.00, 1.34, P = 0.08] Early tracheostomy Rumbak 2004
APPENDICES
Appendix 1. Glossary of terms
Term Definition
COPD (Chronic obstructive pulmonary disease) A disease of chronic diffuse irreversible airflow obstruction. Subcategories of
COPD include chronic bronchitis and pulmonary emphysema
Critically ill adults Adults with a disease or in a state in which death is possible or imminent
Early tracheostomy Although not precisely defined, it usually refers to a tracheostomy performed
from two days to 10 days after intubation
Late tracheostomy Although not precisely defined, it usually refers to a tracheostomy performed
after 10 days of intubation
Percutaneous tracheostomy Usually a tracheostomy based on: 1) needle-guide wire airway access followed by
serial dilations with sequentially larger dilators; 2) guide wire dilating forceps; 3)
mini tracheostomy only for emergency airway access or for aspiration of retained
bronchopulmonary secretions

(Continued)
Pneumomediastinum or mediastinal emphysema Presence of air in the mediastinal tissues due to leakage of air from the tracheo-
bronchial tree, usually as a result of trauma
Pneumothorax An accumulation of air or gas in the pleural space, which may occur spontaneously
or as a result of trauma or a pathological process, or be deliberately introduced
Prolonged mechanical ventilation At least 21 consecutive days for six or more hours per day of any method of artifical
breathing that employs mechanical or non-mechanical means to force the air into
and out of the lungs. Artificial respiration or ventilation is used in individuals
who have stopped breathing or have respiratory insufficiency to increase their
intake of oxygen (O2 ) and excretion of carbon dioxide (CO2 ).
Ramsay score (Ramsay 2000) Numeric scale of responses to verbal, tactile or nociceptive stimuli
Self-extubations Unplanned removal of an endotracheal airway tube by a patient
Severe hypoxia Referred to as low oxygen levels or anoxia and is a relatively common cause of
injury to the central nervous system. Prolonged brain anoxia may lead to brain
death or a persistent vegetative state. Histologically, this condition is characterized
by neuronal loss which is most prominent in the hippocampus; globus pallidus;
cerebellum; and inferior olives
Surgical tracheostomy Tracheostomy performed by surgeons in the operating theatre using an open
technique
Tracheal aspiration Aspiration or suctioning of oropharyngeal secretions past tracheal cuffs into the
lungs in mechanically ventilated patients (usually in the intensive care unit (ICU)
)
Ventilator-associated pneumonia Serious inflammation of the lungs in patients who required the use of a pulmonary
ventilator. it is usually caused by cross-bacterial infections in hospitals (nosocomial
infections)
Appendix 2. Search strategy - MEDLINE (via the PubMed interface)

#1 (“Tracheostomy”[mesh] OR Tracheostomies OR Tracheotomy OR Tracheotomies) AND (((early or precocious or premature) and
(late or tardy)) OR (Artificial Respiration) OR (Artificial Respirations) OR (“Respirations, Artificial”[mesh]) OR (Ventilation, Mechan-
ical) OR (Mechanical Ventilation) OR (Mechanical Ventilations) OR (Ventilations, Mechanical) OR (High-Frequency-Ventilation)
OR (High-Frequency Ventilations) OR (Ventilations, High-Frequency) OR (Ventilation, High Frequency) OR (Ventilation, High-
Frequency) OR (High Frequency Ventilation) OR (High Frequency Ventilations) OR (Ventilations, High Frequency) OR (High-Fre-
quency Oscillation Ventilation) OR (High-Frequency Oscillation Ventilations) OR (Oscillation Ventilation, High-Frequency) OR (Os-
cillation Ventilations, High-Frequency) OR (Ventilation, High-Frequency Oscillation) OR (Ventilations, High-Frequency Oscillation)
OR (High Frequency Oscillation Ventilation) OR (High-Frequency Positive Pressure Ventilation) OR (High Frequency Positive Pres-
sure Ventilation) OR (High-Frequency Jet Ventilation) OR (High-Frequency Jet Ventilations) OR (Jet Ventilation, High-Frequency)
OR (Jet Ventilations, High-Frequency) OR (Ventilation, High-Frequency Jet) OR (Ventilations, High-Frequency Jet) OR (Ventilation,
High Frequency Jet) OR (High Frequency Jet Ventilation) OR (Ventilator-Weaning) OR (Ventilator Weaning) OR (Weaning, Ventila-
tor) OR (Respirator Weaning) OR (Weaning, Respirator) OR (Mechanical Ventilator Weaning) OR (Ventilator Weaning, Mechanical)
OR (Weaning, Mechanical Ventilator) OR (Ventilators, Mechanical) OR (Mechanical Ventilator) OR (Mechanical Ventilators) OR
(Ventilator, Mechanical) OR (Ventilator, Pulmonary) OR (Pulmonary Ventilators) OR (Pulmonary Ventilator) OR (Respirators) OR
(Respirator) OR (Ventilators, Pulmonary) OR (Ventilators) OR (Ventilator) OR (Respiration, Artificial) OR (Artificial Respiration)
OR (Artificial Respirations) OR (Respirations, Artificial) OR (Ventilation, Mechanical) OR (Mechanical Ventilation) OR (Mechanical
Ventilations) OR (Ventilations, Mechanical) OR (Chest Tubes) OR (Chest Tubes) OR (Chest Tube) OR (Tube, Chest) OR (Tubes,
Chest) OR (Laryngeal Masks) OR (Laryngeal Mask) OR (Mask, Laryngeal) OR (Masks, Laryngeal) OR (Laryngeal Mask Airway) OR
(Airway, Laryngeal Mask) OR (Airways, Laryngeal Mask) OR (Laryngeal Mask Airways) OR (Ventilators, Mechanical) OR (Mechan-
ical Ventilator) OR (Mechanical Ventilators) OR (Ventilator, Mechanical) OR (Ventilator, Pulmonary) OR (Pulmonary Ventilators)
OR (Pulmonary Ventilator) OR (Respirators) OR (Respirator) OR (Ventilators, Pulmonary) OR (Ventilators) OR (Ventilator))
#2 ((randomized controlled trial [pt]) OR (controlled clinical trial [pt]) OR (randomized [tiab]) OR (placebo [tiab]) OR (drug therapy
[sh]) OR (randomly [tiab]) OR (trial [tiab]) OR (groups [tiab])) AND (humans [mh])
#3 #1 and #2
Appendix 3. Search strategy - The Cochrane Library

(Tracheostomy OR Tracheostomies OR Tracheotomy OR Tracheotomies) AND (((early or precocious) and (late)) OR (Artificial Res-
piration) OR (Artificial Respirations) OR (Ventilation, Mechanical) OR (Mechanical Ventilation) OR (Mechanical Ventilations) OR
(High-Frequency-Ventilation) OR (High-Frequency Ventilations) OR (High Frequency Ventilation) OR (High Frequency Ventila-
tions) OR (High-Frequency Oscillation Ventilation) OR (High-Frequency Oscillation Ventilations) OR (High Frequency Oscillation
Ventilation) OR (High-Frequency Positive Pressure Ventilation) OR (High Frequency Positive Pressure Ventilation) OR (High-Fre-
quency Jet Ventilation) OR (High-Frequency Jet Ventilations) OR (High Frequency Jet Ventilation) OR (Ventilator-Weaning) OR
(Ventilator Weaning) OR (Respirator Weaning) OR (Mechanical Ventilator Weaning) OR (Mechanical Ventilator) OR (Mechanical
Ventilators) OR (Pulmonary Ventilators) OR (Pulmonary Ventilator) OR (Respirators) OR (Respirator) OR (Ventilators) OR (Venti-
lator) OR (Artificial Respiration) OR (Artificial Respirations) OR (Mechanical Ventilation) OR (Mechanical Ventilations) OR (Chest
Tubes) OR (Chest Tubes) OR (Chest Tube) OR (Laryngeal Masks) OR (Laryngeal Mask) OR (Laryngeal Mask Airway) OR (Laryngeal
Mask Airways) OR (Mechanical Ventilator) OR (Mechanical Ventilators) OR (Pulmonary Ventilators) OR (Pulmonary Ventilator)
OR (Respirators) OR (Respirator) OR (Ventilators) OR (Ventilator))
Appendix 4. Search strategy - EMBASE

#1 (early OR precocious AND late OR ’high frequency ventilation’/exp OR ’high frequency ventilation’ OR (’high frequency’ AND
ventilations) OR (ventilations, AND ’high frequency’) OR (ventilation, AND high AND frequency) OR (ventilation, AND ’high
frequency’) OR (high AND frequency AND (’ventilation’/exp OR ventilation)) OR (high AND frequency AND ventilations) OR
(ventilations, AND high AND frequency) OR (’high frequency’ AND (’oscillation’/exp ORoscillation) AND (’ventilation’/exp OR
ventilation)) OR (’high frequency’ AND (’oscillation’/exp OR oscillation) AND ventilations) OR (’oscillation’/exp OR oscillation AND
ventilation, AND ’high frequency’) OR (’oscillation’/exp OR oscillation AND ventilations, AND ’high frequency’) OR (ventilation,
AND ’high frequency’ AND (’oscillation’/exp OR oscillation)) OR (ventilations, AND ’high frequency’ AND (’oscillation’/exp OR
oscillation)) OR (high AND frequency AND (’oscillation’/exp OR oscillation) AND (’ventilation’/exp OR ventilation)) OR (’high
frequency’ AND positive AND (’pressure’/exp OR pressure) AND (’ventilation’/exp OR ventilation)) OR (high AND frequency
ANDpositive AND (’pressure’/exp OR pressure) AND (’ventilation’/exp OR ventilation)) OR (’high frequency’ AND jet AND
(’ventilation’/exp ORventilation)) OR (’high frequency’ AND jet AND ventilations) OR (jet AND ventilation, AND ’high frequency’)
OR (jet AND ventilations, AND’high frequency’) OR (ventilation, AND ’high frequency’ AND jet) OR (ventilations, AND ’high
frequency’ AND jet) OR (ventilation, AND highAND frequency AND jet) OR (high AND frequency AND jet AND (’ventilation’/
exp OR ventilation)) OR ’ventilator weaning’/exp OR ’ventilator weaning’ OR (’ventilator’/exp OR ventilator AND (’weaning’/
exp OR weaning)) OR (weaning, AND (’ventilator’/exp OR ventilator)) OR (’respirator’/exp OR respirator AND (’weaning’/exp
OR weaning)) OR (weaning, AND (’respirator’/exp OR respirator)) OR (mechanical AND (’ventilator’/exp OR ventilator) AND
(’weaning’/exp OR weaning)) OR (’ventilator’/exp OR ventilator AND weaning, AND mechanical) OR (weaning, AND mechanical
AND (’ventilator’/exp OR ventilator)) OR (respiration, AND artificial) OR (artificial AND (’respiration’/exp OR respiration)) OR
(artificial AND respirations) OR (respirations, AND artificial) OR (ventilation, AND mechanical) OR (mechanical AND (’ventilation’/
exp OR ventilation)) OR (mechanical AND ventilations) OR (ventilations, AND mechanical) OR (’chest’/exp OR chest ANDtubes)
OR (’chest’/exp OR chest AND (’tube’/exp OR tube)) OR (tube, AND (’chest’/exp OR chest)) OR (tubes, AND (’chest’/exp OR chest))
OR (laryngeal AND (’masks’/exp OR masks)) OR (laryngeal AND (’mask’/exp OR mask)) OR (mask, AND laryngeal) OR (masks,
ANDlaryngeal) OR (laryngeal AND (’mask’/exp OR mask) AND (’airway’/exp OR airway)) OR (airway, AND laryngeal AND (’mask’/
exp OR mask)) OR (airways, AND laryngeal AND (’mask’/exp OR mask)) OR (laryngeal AND (’mask’/exp OR mask) AND airways)
OR (ventilators, ANDmechanical) OR (mechanical AND (’ventilator’/exp OR ventilator)) OR (mechanical AND ventilators) OR
(ventilator, AND mechanical) OR (ventilator, AND pulmonary) OR (pulmonary AND ventilators) OR (pulmonary AND (’ventilator’/
exp OR ventilator)) OR respirators OR’respirator’/exp OR respirator OR (ventilators, AND pulmonary) OR ventilators OR ’ventilator’/
exp OR ventilator) AND (’tracheostomy’/exp OR tracheostomy OR tracheostomies OR ’tracheotomy’/exp OR tracheotomy OR
tracheotomies)
#2 (random$ OR factorial$ OR crossover$ OR (cross AND over$) OR ’cross over$’ OR placebo$ OR (doubl$ AND adj AND blind$)
OR (singl$AND adj AND blind$) OR assign$ OR allocat$ OR volunteer$ OR ’crossover procedure’/exp OR ’crossover procedure’
OR (’double blind’ ANDprocedure) OR (randomized AND controlled AND trial) OR (’single blind’ AND procedure))
#3 #1 and #2
Appendix 5. Search strategy - LILACS

(Tracheostomy OR Traqueostomia OR Tracheostomies OR Traqueostomias OR Tracheotomy OR Tracheotomies) AND (((early or
precocious) and (late)) OR (Artificial Respiration) OR (Artificial Respirations) OR (Ventilation, Mechanical) OR (Mechanical Ven-
tilation) OR (Mechanical Ventilations) OR (High-Frequency-Ventilation) OR (High-Frequency Ventilations) OR (High Frequency
Ventilation) OR (High Frequency Ventilations) OR (High-Frequency Oscillation Ventilation) OR (High-Frequency Oscillation Ven-
tilations) OR (High Frequency Oscillation Ventilation) OR (High-Frequency Positive Pressure Ventilation) OR (High Frequency
Positive Pressure Ventilation) OR (High-Frequency Jet Ventilation) OR (High-Frequency Jet Ventilations) OR (High Frequency Jet
Ventilation) OR (Ventilator-Weaning) OR (Ventilator Weaning) OR (Respirator Weaning) OR (Mechanical Ventilator Weaning) OR
(Mechanical Ventilator) OR (Mechanical Ventilators) OR (Pulmonary Ventilators) OR (Pulmonary Ventilator) OR (Respirators) OR
(Respirator) OR (Ventilators) OR (Ventilator) OR (Artificial Respiration) OR (Artificial Respirations) OR (Mechanical Ventilation)
OR (Mechanical Ventilations) OR (Chest Tubes) OR (Chest Tubes) OR (Chest Tube) OR (Laryngeal Masks) OR (Laryngeal Mask) OR
(Laryngeal Mask Airway) OR (Laryngeal Mask Airways) OR (Mechanical Ventilator) OR (Mechanical Ventilators) OR (Pulmonary
Ventilators) OR (Pulmonary Ventilator) OR (Respirators) OR (Respirator) OR (Ventilators) OR (Ventilator))
Appendix 6. Search strategy - Current Controlled Trials

(tracheostomy or tracheostomies) and (timing or ((early or precocious) and (late or later)))
Appendix 7. Search strategy - PEDro

tracheostomy or tracheostomies
Appendix 8. Search strategy - CINAHL

(Tracheostomy OR Tracheostomies) and (early and late)
Appendix 9. Extraction Sheet

Study ID: Date of Study (year): Review ID:
Reviewer:
Author (last name):

Local of study:

I - ACTION
Contact author for:
II - PARTICIPANTS
Participants
a. N:
b. Age (mean):
c. Diagnosis (e.g., burning, lung disease, etc):
d. Method to characterize patients as ’critically ill’
e. Method to predict prolonged artificial ventilation:
f. Gender:
g. Setting:
h. Statistical differences at baseline:
III - INTERVENTIONS
Early tracheostomy:
Timing of tracheotomies [days (e.g., from day 0 of mechanical ventilation)]:
Type of tracheostomy, (e.g., percutaneous or surgical tracheostomy)

Late tracheostomy:
Timing of tracheotomies [days (e.g., from day 0 of mechanical ventilation)]:
Type of tracheostomy, (e.g., percutaneous or surgical tracheostomy)
IV - OUTCOMES
(final or change from baseline values)

Primary outcomes
1. mortality (time to mortality or frequency at any time point: in hospital, in ICU, after discharge);
2. duration of artificial ventilation.
Secondary outcomes
1. length stay in the ICU (or frequency at any time point);
2. ventilator-associated pneumonia at any time point;
3. laryngotracheal lesions at any time point (in epiglottis, vocal cord, larynx, subglottic ulceration and inflammation);
4. eating/vocal/speech problems.

V - METHODOLOGICAL QUALITY OF STUDY
Please, mark the appropriated item

Was the random allocation sequence adequately generated?
Low risk:
High risk:
Unclear
Was allocation adequately concealed?
Low risk
High risk
Unclear
Blinding: was knowledge of the allocated interventions adequately prevented during the study?
Low risk
High risk
Unclear
Were incomplete outcome data adequately addressed?
Low risk
High risk
Unclear
Are reports of the study free of suggestion of selective reporting?
Low risk
High risk
Unclear
Other bias?
Low risk:
High risk
Unclear
VI - Observation (including non-published data)
Appendix 10. Non-parameric estimate effects not possible to be combined in a meta-analysis
Study ID Comparison groups Median Interquartile range P-value
Outcome: Ventilator free-days (at day 28)
Terragni 2010 Early tracheostomy 11 0-21 0.02
Late tracheostomy 6 0-17
Outcome: ICU free-days (at day 28)
Terragni 2010 Early tracheostomy 0 0-13
Late tracheostomy 0 0-8 0.02

(Continued)
Outcome: Hospital length of stay (days)
Terragni 2010 Early tracheostomy 31 17-39 not available
Late tracheostomy 32 18-59
Appendix 11. Other potentially relevant outcomes not planned in the protocol of this systematic
review
Outcome n Estimate effect (MD or RR, Favoured group Study

95% CI, P, NNT, CI 95% for
NNT)
1. Need for a long-term 292 RR 1.09 [0.81, 1.46, P=0.59] Late tracheostomy Terragni 2010
care facility
2. Time spent on seda- 120 MD -10.90 [-11.64, -10.16, Early tracheostomy Rumbak 2004
tion (days) P<0.00001]
3. Time spent on high- 120 MD 0.50 [-1.02, 2.02, P=0.52] Late tracheostomy Rumbak 2004
dose pressors (days)
4. Any event followed by death
4.1 Ventilator-associated 120 RR 0.22 [0.05, 0.99, P=0.05, Early tracheostomy Rumbak 2004
pneumonia NNT=4.54]
4.2 Gastrointestinal 120 RR 0.33 [0.04, 3.11, P=0.34] Early tracheostomy Rumbak 2004
bleed
4.3 Acute myocardial in- 120 RR 0.50 [0.10, 2.63, P=0.41] Early tracheostomy Rumbak 2004
farction
4.4 Pulmonary embolus 120 RR 1.00 [0.06, 15.62, P=1.00] Early tracheostomy Rumbak 2004
4.5 Intractable septic 120 RR 0.50 [0.16, 1.57, P=0.24] Early tracheostomy Rumbak 2004
shock
4.6 Withdrawal of life 120 RR 2.00 [0.19, 21.47, P=0.57] Late tracheostomy Rumbak 2004
support
4.7 Respiratory failure 120 RR 0.64 [0.26, 1.53, P=0.31] Early tracheostomy Rumbak 2004
5. Intraoperative adverse events

(Continued)
5.1 Minor bleeding 264 RR 0.55 [0.09, 3.22, P=0.50] Early tracheostomy Terragni 2010
5.2 Significant bleeding 264 no event in both groups - Terragni 2010
5.3 Tube dislocation 264 RR 0.55 [0.09, 3.22, P=0.50] Early tracheostomy Terragni 2010
5.4 Hypoxaemia 264 RR 1.15 [0.37, 3.53, P=0.81] Late tracheostomy Terragni 2010
5.5 Arrhyhtmia 264 no event in both groups - Terragni 2010
HISTORY
Protocol first published: Issue 3, 2008
Review first published: Issue 3, 2012
Date Event Description
19 May 2010 Amended Contact details updated.
CONTRIBUTIONS OF AUTHORS
Conceiving the review: Brenda NG Silva (BGS) and Álvaro N Atallah (ANA)
Co-ordinating the review: BGS and Humberto Saconato (HS)
Undertaking manual searches: BGS
Screening search results: BGS
Organizing retrieval of papers: BGS
Screening retrieved papers against inclusion criteria: BGS, RA and HS
Appraising quality of papers: BGS, Regis B Andriolo (RA) and HS
Abstracting data from papers: BGS, RA and Orsine Valente (OV)
Writing to authors of papers for additional information: BGS and RA
Providing additional data about papers: BGS and RA
Obtaining and screening data on unpublished studies: BGS and RA
Data management for the review: BGS and RA
Entering data into Review Manager (RevMan 5.1): BGS and RA
RevMan statistical data: BS and RA
Other statistical analysis not using RevMan: RA
Double entry of data: (data entered by person one - RA)
Interpretation of data: BGS, OV and RA
Statistical inferences: BGS, HS and RA
Writing the review: BGS, OV and RA
Guarantor for the review (one author): BGS
Persons responsible for reading and checking review before submission: OV and ANA
DECLARATIONS OF INTEREST
The lead author (Brenda NG Silva) has been working as a respiratory therapist since 2002.
All other authors: none known.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
Types of outcome measures

The following sentence was inserted in the final version ’Types of outcome measures’.
Evaluation of the internal validity of included studies

At the time the protocol was prepared, the items of internal validity were compatible with previous versions of the Cochrane Handbook
(Higgins 2011c), as listed below. However, the first full version of this review was prepared according to the updated Cochrane Handbook
(Higgins 2011a).
Selection bias
Was allocation concealment adequate and were data similar at baseline?
A: adequate allocation concealment and similar descriptive data between arms at baseline;
B: not described;
C: not adequate.
Detection bias
Was there a blinded assessment of outcomes?
Met: assessors unaware of the assigned treatment when collecting outcome measures;
Unclear: blinding of assessor not reported and cannot be verified by contacting investigators;
Not met: assessors aware of the assigned treatment when collecting outcome measures.

Attrition bias
Were there any withdrawals described and were they acceptable?
Met: no substantial loss of participants after randomization or difference between comparison groups not statistically significant;
Unclear: losses not reported by the authors;
Not met: substantial loss of participants after randomization or statistically significant difference in losses between comparison groups.
Performance bias
We will not use blinding of providers and patients as a criterion to assess internal validity of included trials because of the nature of the
intervention.
Sensitivity analysis
The inclusion of a study with different times of early and late tracheostomies than our inclusion criteria was considered in a sensitivity
analysis.


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Early versus late tracheostomy for critically ill patients

Gomes Silva BN, Andriolo RB, Saconato H, Atallah ÁN, Valente O

Early versus late tracheostomy for critically ill patients (Review)

Early versus late tracheostomy for critically ill patients (Review) i

Early versus late tracheostomy for critically ill patients

Editorial group: Cochrane Anaesthesia Group.

PLAIN LANGUAGE SUMMARY

Early versus late tracheostomy for critically ill patients (Review) 2

Early tracheostomy compared to late tracheostomy for critically ill patients

Patient or population: patients with critically ill patients

Assumed risk/mean dif- Corresponding risk

Late tracheostomy Early tracheostomy

Mortality at maximal fol- 193/301 148/298 Not estimable 599 ⊕⊕

Pneumonia 59/270 33/269 Not estimable 539 ⊕⊕

GRADE Working Group grades of evidence

as showed by the 95% CI of -11.48 to -8.12 (P <0.00001)

Description of the intervention Why it is important to do this review

Early versus late tracheostomy for critically ill patients (Review) 5

Search methods for identification of studies

Early versus late tracheostomy for critically ill patients (Review) 6

Unit of analysis issues Subgroup analysis and investigation of heterogeneity

Early versus late tracheostomy for critically ill patients (Review) 7

We planned to only conduct these analyses if data were available

Early versus late tracheostomy for critically ill patients (Review) 8

Early versus late tracheostomy for critically ill patients (Review) 9

We included four studies available in English language journals

Early versus late tracheostomy for critically ill patients (Review) 10

Early versus late tracheostomy for critically ill patients (Review) 11

Early versus late tracheostomy for critically ill patients (Review) 12

Early versus late tracheostomy for critically ill patients (Review) 13

Early versus late tracheostomy for critically ill patients (Review) 14

Implications for research

Agle 2006 Christensen 2006

Early versus late tracheostomy for critically ill patients (Review) 17

Early versus late tracheostomy for critically ill patients (Review) 18

Early versus late tracheostomy for critically ill patients (Review) 19

Characteristics of included studies [ordered by study ID]

Participants • N=60 (early tracheostomy, n = 29 / late tracheostomy, n = 31)

Interventions 1. Early tracheostomy: before day 8

Bias Authors’ judgement Support for judgement

Early versus late tracheostomy for critically ill patients (Review) 20

Random sequence generation (selection Low risk Computer-generated table

Other bias High risk Although times of follow-up were explicitly

Participants • N=74 (Early tracheostomy, n = 34 / Late tracheotomy, n = 40)

Early versus late tracheostomy for critically ill patients (Review) 21

Outcomes • Significant laryngotracheal pathology (irrespective of type) that required surgery

Bias Authors’ judgement Support for judgement

Early versus late tracheostomy for critically ill patients (Review) 22

Participants • N: 120 (Early tracheostomy, n = 60 / Late tracheostomy, n = 60)

Interventions 1. Tracheotomy within 48 hours after intubation

Early versus late tracheostomy for critically ill patients (Review) 23

Notes Method to predict prolonged artificial ventilation: Not explicitly reported

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Not explicitly reported.

Participants • N= 419 (Early tracheostomy, n = 209 / Late tracheostomy, n = 210)

Early versus late tracheostomy for critically ill patients (Review) 24

the neck (including thyromegaly) and cervical tumors; a history of oesophageal,

Interventions 1. Early tracheostomy: After six to eight days of laryngeal intubation

Outcomes • Mortality (28 days)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Computer-generated randomization

Early versus late tracheostomy for critically ill patients (Review) 25

nonobjective components of the CPIS (qual-