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Systematic Review

Otolaryngology–
Head and Neck Surgery

Early versus Late Tracheostomy: A 2015, Vol. 152(2) 219–227


Ó American Academy of
Otolaryngology—Head and Neck
Systematic Review and Meta-Analysis Surgery Foundation 2014
Reprints and permission:
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DOI: 10.1177/0194599814561606
http://otojournal.org
C. Carrie Liu, MD1, Devon Livingstone, MD1,
Elijah Dixon, MD, MSc2, and Joseph C. Dort, MD, MSc1,3

T
No sponsorships or competing interests have been disclosed for this article. racheostomy is one of the most commonly performed
procedures in the critical care population.1 A common
indication for its performance is in the event of pro-
Abstract
longed intubation and ventilation.2 Compared with endotracheal
Objective. To investigate whether early tracheostomy leads intubation, the proposed advantages of tracheostomy are that it
to improved outcomes compared with late tracheostomy. facilitates weaning from mechanical ventilation, allows for
Data Sources. Ovid MEDLINE (including PubMed), Embase, quicker resumption of speech and oral intake, and is more com-
and the Cochrane Central Register of Controlled Trials. fortable for the patient.1-4 Another proposed advantage of tra-
cheostomy is that there is a lower risk of laryngeal injury. Rates
Review Methods. A systematic search was performed of the of early laryngeal injury following endotracheal intubation have
above-mentioned databases according to PRISMA guide- been reported to be as high as 94%.5 Long-term sequelae such
lines. Data were collected on the following outcomes of as granulomas and laryngeal stenosis range from 5% to 12%,5,6
interest: hospital mortality, intensive care unit length of with increased length of endotracheal intubation associated with
stay, length of mechanical ventilation, incidence of pneu- a higher incidence of stenosis.6 With the development of more
monia, laryngotracheal injury, and sedation use. Analysis flexible tubes with low-pressure cuffs and improved tube man-
was performed using the RevMan 5 software (Cochrane agement strategies, laryngeal injury and the related sequelae are
Collaboration, Oxford, England). less common.4 Laryngeal injury, however, remains an important
Results. Eleven studies were included for analysis. There was a risk as the course of intubation lengthens.7
significant decrease in the intensive care unit length of stay in The optimal timing of tracheostomy in critically ill patients
the early tracheostomy group (weighted mean difference, requiring prolonged mechanical ventilation is debated.
29.13 days; 95% confidence interval [CI], 217.55 to Convention dictates that a tracheostomy may be performed if
20.70; P = .03). There was no significant difference in hos- the course of mechanical ventilation exceeds 14 days.7 A con-
pital mortality (relative risk, 0.84; 95% CI, 0.67 to 1.04; P = sensus conference held in 1989 stated that patients who require
.11). A pooled analysis was not performed for the incidence mechanical ventilation for up to 10 days may be endotrache-
of pneumonia or length of mechanical ventilation, secondary ally intubated, whereas tracheostomy is favored if mechanical
to considerable heterogeneity among the studies. None of ventilation is predicted to be greater than 21 days.2 The evi-
the studies reporting laryngotracheal outcomes found a signif- dence for this, however, is limited and a defined pathway for
icant difference between the early and late tracheostomy
1
groups, whereas all 3 studies reporting sedation use found a Division of Otolaryngology–Head and Neck Surgery, Department of
significant decrease in the early tracheostomy group. Surgery, University of Calgary, Alberta, Canada
2
Division of General Surgery, Department of Surgery, University of Calgary,
Conclusion. Early tracheostomy performed within 7 days of intuba- Alberta, Canada
3
tion was associated with a decrease in intensive care unit length of Ohlson Research Initiative, University of Calgary, Alberta, Canada
stay. No difference was found in hospital mortality. Insufficient data This article was presented at the 2014 AAO-HNSF Annual Meeting & OTO
currently exist to make conclusions about the effect of early tra- EXPO; September 21-24, 2014; Orlando, Florida.
cheostomy on the incidence of pneumonia, length of mechanical Corresponding Author:
ventilation, laryngotracheal injury, or sedation use. Joseph C. Dort, Division of Otolaryngology–Head and Neck Surgery,
Department of Surgery, Ohlson Research Initiative, University of Calgary,
HRIC 2A02, 3280 Hospital Dr. NW, Calgary, AB, T2N 4Z6, Canada.
Keywords Email: jdort@ucalgary.ca

tracheostomy, tracheotomy, prolonged intubation, systema-


tic review, meta-analysis A podcast for this article is available at
http://otojournal.org. Scan this code with
Received July 8, 2014; revised October 13, 2014; accepted November your phone to hear the podcast instantly.
6, 2014.
220 Otolaryngology–Head and Neck Surgery 152(2)

the management of the airway in this population of patients Statistical Analysis


does not exist.7,8 Relative risk (RR) with 95% confidence intervals (CIs) was
Our goal in this study is to perform a systematic review used to express differences for dichotomous variables.
and meta-analysis of existing literature, investigating whether Weighted mean differences (WMDs) with 95% CIs were
early tracheostomy leads to improved outcomes compared used for continuous variables. The I2 statistic was used to
with late tracheostomy in critically ill patients. quantify heterogeneity, whereby I2 of 0% to 40% might not
be important, 30% to 60% may indicate moderate heteroge-
Methods neity, 50% to 90% may indicate substantial heterogeneity,
Search Strategy and Study Selection and 75% to 100% indicates considerable heterogeneity.12
We only performed pooled analysis when the heterogeneity
A systematic search was performed according to PRISMA
was less than 60%. Data analysis was performed using a
(Preferred Reporting Items for Systematic Reviews and
random-effects model, given the varied patient populations
Meta-Analyses) guidelines by 2 reviewers (C.C.L. and D.L.).
and study methodologies. A P value of \.05 was considered
The MEDLINE (including PubMed) and Embase databases
significant. Where meta-analysis was performed, sensitivity
were searched using key terms tracheo$ and intubation,
analysis was undertaken by removing individual studies
whereby the symbol $ denotes the inclusion of all variations
from the pooled results to assess the extent to which each
of the term beginning with the stem tracheo (ie, to include
study contributed to the effect size and heterogeneity.
both tracheostomy and tracheotomy). The search terms tra-
RevMan 5 software (Cochrane Collaboration, Oxford,
cheo$ and intubation were each cross-searched with the
England) was used for all statistical analyses.
MeSH term time factors to identify studies that examine the
Subgroup analysis was performed to investigate whether
timing of tracheostomy and intubation. The Cochrane Central
certain clinical or methodological characteristics of the
Register of Controlled Trials (CENTRAL) database was also
studies could account for the statistical heterogeneity seen
searched using the key words tracheostomy and tracheotomy.
and whether these characteristics influenced the results of
Studies were limited to those published over the past 30
the meta-analysis. Specifically, we performed subgroup
years (January 1, 1983, through September 1, 2013), in the
analysis based on the timing of the early tracheostomy (ie,
English language, and involving human subjects. The biblio-
3 days, 4-5 days, 7-8 days), as studies differed in their
graphies of relevant studies were hand-searched to identify
definitions of early and late tracheostomy. We also exam-
any additional studies.
ined outcomes based on the etiology of acute illness of the
Title and abstract review was performed once the initial list
study population.
of studies was generated. The reviewers met prior to commen-
This study contains only data from the published literature,
cing study selection to ensure consistency in the application of
and no patient data were used; therefore, institutional review
the inclusion criteria. Studies were selected if they met the 4
board and ethics committee approval was not required.
inclusion criteria: (1) the study was a randomized or quasi-
randomized trial in design, (2) participants were critically ill
patients requiring prolonged mechanical ventilation, (3) the Results
study examined the outcomes of early tracheostomy compared A total of 3893 studies were identified following the initial
with late tracheostomy, and (4) the outcomes included at least search. A title and abstract review excluded 3873 studies,
one of the following: hospital mortality, length of intensive leaving 20 studies for full-text review. One additional study
care unit (ICU) stay, length of mechanical ventilation, inci- was identified during the bibliography search of relevant
dence of pneumonia, laryngotracheal injury, or sedation use. studies for a total of 21 studies. Following full-text review,
A full-text review was performed of any remaining stud- 11 studies remained (Figure 1). Table 1 summarizes the
ies following the title and abstract review. Additional stud- key features of the included studies, and Table 2 sum-
ies that did not meet inclusion criteria were excluded. marizes the risk of bias assessment. The etiology of the crit-
ical illness of the study populations varied from medical,
Data Collection neurological, traumatic, to mixed. The timing of the early
The outcomes of interest were hospital mortality, length of tracheostomy differed significantly across studies, ranging
mechanical ventilation, length of ICU stay, incidence of pneu- from 2 to 8 days. The definition of late tracheostomy also
monia, laryngotracheal injury, and sedation use. A detailed varied, ranging from 6 to 28 days. In 2 studies, late tra-
data collection sheet was created based on the outcomes of cheostomies were performed during a time frame that fell
interest. This underwent multiple revisions by the reviewers into most other studies’ definitions of early tracheost-
before data collection to ensure usability and consistency. Data omy.13,14 This overlapping of groups may cause inaccurate
were collected independently by 3 reviewers (C.C.L., E.D., results in a meta-analysis, as the effects attributed to
and J.D.). During the data collection process, the risk of bias patients in the late groups in these studies may negate simi-
for each study was assessed. Various risk of bias scales exist, lar effects attributed to patients in the early groups in other
and there is no one scale that is clearly validated.9-11 We studies. As such, these studies were not included in the
chose to use the criteria from the Cochrane Handbook for pooled analyses. No life-threatening complications were
Systematic Reviews of Interventions.12 reported in any of the studies.
Liu et al 221

Incidence of Pneumonia
Medline, Embase search terms:
tracheo$ OR intubation AND time factors Eight studies reported the incidence of pneumonia as an out-
Cochrane Central Register for Controlled Trials
come.15-22 Two studies used the clinical pulmonary infec-
search terms:
tracheostomy, tracheotomy
tion score (CPIS) to diagnose pneumonia.21,22 Four studies
used varying combinations of leukocyte count, the presence
of fevers, chest x-ray findings, and bronchial cultures to
Limits make the diagnosis of pneumonia,15,18-20 while 2 studies did
01/01/1983 09/01/2013
Human research not specify their method of diagnosis.16,17 The crude cumula-
English language tive incidence of pneumonia was 35.9% in the early tra-
cheostomy groups (185 of 515 patients) and 45.5% of
patients in the late tracheostomy groups (244 of 536 patients).
Medline 2873 studies 516 duplicates removed
Embase 1226 studies A pooled analysis was not performed secondary to significant
CENTRAL 310 studies
Title & Abstract Review heterogeneity of the measured effects from the individual
3873 studies excluded:
Not pertaining to the timing of
studies. Figure 2 summarizes the results from each study
3893 studies
tracheostomy in patients requiring
prolonged mechanical ventilation
without an overall pooled analysis. Three studies reported a
Not randomized or quasi- significant decrease in the incidence of pneumonia in the
randomized trials in design
early tracheostomy group.17,18,22 Two studies showed a non-
20 studies 1 additional study found through significant trend that favored the early tracheostomy
hand search of article bibliographies
group,20,21 while the remaining 3 suggested a slight increase
Full Text Review
10 studies excluded: in pneumonia in the early tracheostomy group.15,16,19
21 studies Not prospective randomized or
quasi-randomized trials in design
Not comparing early and late
tracheostomy
Length of Mechanical Ventilation
11 studies to be included in
review Four studies reported the length of mechanical ventilation as an
Figure 1. Search strategy. outcome.17-19,23 The average length of mechanical ventilation

Table 1. Characteristics of Included Studies.


No. of Patients in No. of Patients Predictor of Day of Day of
Study Early Tracheosto in Late Tracheosto Prolonged Early Late Tracheostomy
Author Year Population my Group my Group Ventilation Tracheostomya Tracheostomyb Method

Dunham and 1984 Trauma 34 40 Clinical judgment 4 14 Open


LaMonica16
Rodriguez 1990 Trauma 51 55 NS 7 8 NS
et al17
Sugerman 1997 Mixed 53 59 Clinical judgment 5 14 Both
et al20
Saffle et al19 2002 Burns 21 23 Validated 4 14 Open
instrument
Rumbak 2004 Medical 60 60 Clinical judgment 2 14 Percutaneous
et al18
Barquist 2006 Trauma 29 31 NS 8 28 Open
et al15
Terragni 2010 Mixed 209 210 Clinical 8 15 Percutaneous
et al21 judgment
Koch et al14 2012 Neuro, neurosurgery, 50 50 Clinical 4 6 Percutaneous
neurotr judgment
Zheng 2012 Medical 58 61 NS 3 15 Percutaneous
et al22
Bosel 2013 Neurological 29 31 Nonvalidated 3 7 Percutaneous
et al13 illness, instrument
neurosurgery,
neurotrauma
Young et al23 2013 Mixed 455 454 Clinical judgment 4 10 Both
Abbreviation: NS, not specified.
a
The latest day on which a tracheostomy is performed in the early tracheostomy group.
b
The earliest day on which a tracheostomy is performed in the late tracheostomy group.
222 Otolaryngology–Head and Neck Surgery 152(2)

Table 2. Risk of Bias of Studies Included in Meta-Analysis.


Sequence Allocation Blinding Incomplete Selective
Generation Concealment (Performance Outcome Data Outcome Reporting
Author (Selection Bias) (Selection Bias) and Detection Bias) Addressed (Attrition Bias) (Reporting Bias) Other Bias

Dunham and High risk High risk Unclear risk High risk High risk High riska
LaMonica16
Rodriguez et al17 High risk High risk High risk High risk High risk Unclear riskb
Sugerman et al20 Low risk Low risk High risk High risk High risk High riskc
Saffle et al19 Low risk Low risk High risk Low risk High risk High riskd
Rumbak et al18 Low risk High risk Unclear risk Low risk Low risk Unclear riskb
Barquist et al15 Low risk Low risk Unclear risk Low risk Low risk High riske
Terragni et al21 Low risk Low risk Low risk Low risk Low risk Unclear riskb
Koch et al14 Low risk Low risk Unclear risk Unclear risk Low risk Unclear riskb
Zheng et al22 Low risk Low risk High risk Low risk High risk High riskf
Bosel et al13 Low risk Low risk High risk Low risk High risk Low risk
Young et al23 Low risk Low risk High risk Low risk Low risk Low risk
a
No information provided on the baseline characteristics of the treatment groups.
b
Where the time for follow-up is not provided for some outcomes, but it is unclear whether this would introduce bias to the study results.
c
Significant amount of data collected but lost and therefore could not be analyzed.
d
Even after randomization, the 2 groups were not equal in all characteristics (eg, presence of full-thickness burns, probability of requiring prolonged ventilator
support).
e
It appears that this study was terminated prior to completion as only the interim results are reported.
f
The patient flow diagram does not add up; it is unclear exactly how they arrived at 119 patients being randomized.

Figure 2. Incidence of pneumonia based on timing of tracheostomy. CI, confidence interval; M-H, Mantel-Haenszel.

Figure 3. Length of mechanical ventilation based on timing of tracheostomy. CI, confidence interval; IV, independent variable.

among these studies was 17 days for the early tracheostomy result (Figure 3). Rodriguez et al17 reported a significantly
group and 24 days for the late tracheostomy group. A pooled decreased length of mechanical ventilation in the early tra-
analysis was attempted, but once again, the heterogeneity was cheostomy group, with a mean difference of 220 days (95%
found to be considerable (I2 = 99%); therefore, we present the CI, 220.8 to 219.2, P \ .05), as did Rumbak et al,18 with a
measured effects from the individual studies without a pooled mean difference of 29.8 days (95% CI, 211.5 to 28.12,
Liu et al 223

Figure 4. Intensive care unit (ICU) length of stay (LoS) based on timing of tracheostomy. CI, confidence interval; IV, independent variable.

Figure 5. Hospital mortality based on timing of tracheostomy. CI, confidence interval; M-H, Mantel-Haenszel.

P \ .001). Young et al23 did not find a significant was no significant reduction in the relative risk (RR, 0.84;
decrease in the length of mechanical ventilation, with a mean 95% CI, 0.67 to 1.04; I2 = 34%, P = .11). When sensitivity
difference of 21.6 days (95% CI, 23.33 to 0.13, P = .06). analysis was performed for this outcome, the Rumbak et al18
Finally, Saffle et al19 found an increase in the length of study was found to contribute to most of the heterogeneity;
mechanical ventilation, with those in the early tracheostomy however, removing this study from the analysis did not
group requiring 4.10 more days than those in the late tra- change the significance of the findings.
cheostomy group (95% CI, 1.23 to 6.97, no P value reported).
Sedation Use and Laryngotracheal Injury
ICU Length of Stay Sedation use and laryngotracheal injury were also outcomes
Four studies reported data on ICU length of stay (Figure of interest in our meta-analysis, as both are of clinical sig-
4).17,18,20,23 The pooled results favored early tracheostomy, with a nificance. Data regarding these outcomes, however, could
weighted mean difference of 29.13 days (95% CI, 217.55 to only be qualitatively summarized as they were heteroge-
20.70, I2 = 100%, P = .03). Sensitivity analysis showed that the neous and could not be combined in a quantitative analysis.
studies were equal in their contribution to the heterogeneity. The Bosel et al13 found a significant decrease in the use of
study results were pooled despite the significant heterogeneity sedatives in the early tracheostomy group compared with
because all of the measured effects were in the same direction, the late tracheostomy group, with each group requiring
favoring early tracheostomy; therefore, the true effect likely also sedatives during 42% and 62% of the ICU stay, respectively
lies in this direction. A pooled analysis in this case likely captures (median difference, 17.5 days; 95% CI, 3.3-29.2; P = .02).
the true effect, despite significant statistical heterogeneity. Furthermore, they found that patients in the early tracheost-
omy group scored lower on the Richmond Agitation
Hospital Mortality Sedation Scale and spent more time under assisted rather
To maximize the information captured and analyzed, we than controlled ventilation. Rumbak et al18 also found a sig-
defined mortality broadly in our protocol as hospital mortal- nificant decrease in sedation use, with a mean (SD) of 3.2
ity. This definition included ICU, 28-day and 30-day mortal- (0.4) days of sedation in the early tracheostomy group com-
ity, and hospital mortality. Eight studies reported data on pared with a mean (SD) of 14.1 (2.9) days of sedation in the
mortality (Figure 5).15,17-23 The proportion of patients who late tracheostomy group (P \ .001). Finally, Young et al23
died in the early tracheostomy group was 30.7%, compared found a significant decrease in the median number of days
with 34.7% in the late tracheostomy group. The weighted of sedation use in the early tracheostomy group compared
absolute risk reduction was not significant. Similarly, there with the late tracheostomy group (5 vs 8 days, P \ .001).
224 Otolaryngology–Head and Neck Surgery 152(2)

Table 3. Incidence of Early and Late Laryngotracheal Complications Based on Timing of Tracheostomy (Expressed as Number of
Complications/Number of Evaluated Patients).
Early Complication Late Complication

Study Early Tracheostomy Late Tracheostomy Early Tracheostomy Late Tracheostomy

Sugerman et al20a Epiglottic ulcers: 0/13 Epiglottic ulcers: 8/32 0 0


VC ulcers: 6/17 VC ulcers: 23/34
Laryngeal ulcers: 0/13 Laryngeal ulcers: 10/31
Laryngeal inflammation: 26/33 Laryngeal inflammation: 4/15
SG ulcers: 1/13 SG ulcers: 4/26
SG inflammation: 0/15 SG inflammation: 11/28
Rumbak et al18b TS TS TS TS
0%-20%: 52/60 0%-20%: 41/60 0%-20%: 26/60 0%-20%: 13/60
21%-50%: 6/60 21%-50%: 12/60 21%-50%: 10/60 21%-50%: 6/60
.50%: 3/60 .50%: 5/60 .50%: 5/60 .50%: 4/60
Dunham and LaMonica16 LT path: 6/34 LT path: 5/40 NA NA

Abbreviations: LT path, laryngotracheal pathology, including subglottic stenosis, granuloma, and supraglottic edema; NA, not assessed in study; SG, subglottic;
TS, tracheal stenosis; VC, vocal cord.
a
Late complications were assessed at 3 to 5 months postextubation in those who were symptomatic or who had an initial injury assessment of Lindholm
class II or worse. Sugerman et al20 presented varying denominators secondary to incomplete data for some outcomes. They also did not specify the number
of patients evaluated for late complications.
b
Late laryngotracheal complications assessed at 10 weeks postintubation.

Only 3 studies investigated the presence and extent of lar- Subgroup Analysis
yngotracheal injury as an outcome.16,18,20 The results from Subgroup analysis was performed to examine whether the
these studies are presented in Table 3. Sugerman et al20 per- pooled results were influenced by the precise timing of the
formed laryngoscopy in 83 of 112 patients, either at the time tracheostomy and the illness population.
of tracheostomy performance or upon extubation. In those who The analyzed studies varied in their definitions of early
received a tracheostomy, 41 underwent laryngoscopy at the time tracheostomy, ranging from 2 to 8 days after intubation.
of decannulation. They found a nonsignificant trend toward a Table 4 summarizes the incidence of pneumonia, length of
higher incidence of airway ulceration and inflammation in the ventilation, length of ICU stay, and hospital mortality based
late tracheostomy group. Specifically, they found a 35.3% inci- on the timing of the early tracheostomy. We did not find a
dence of vocal cord ulceration in the early tracheostomy group significant difference in any of the outcomes of interest
compared with 67.6% in the late tracheostomy group, while based on the timing of tracheostomy.
subglottic inflammation was found in 0% and 39.3% of the The studies encompassed a variety of patients, including
early and late tracheostomy groups, respectively. The incidence trauma, neurological, medical, and mixed medical, and sur-
of ulceration and inflammation at other laryngotracheal sites is gical. Therefore, subgroup analysis was performed with
shown in Table 3. Patients who were symptomatic or had an regard to the etiology of critical illness to determine
initial injury of Lindholm class II or worse were reassessed at 3 whether specific populations of patients were more likely to
to 5 months. No evidence of late complications was found in benefit from an early tracheostomy. A pooled analysis did
either the early or late tracheostomy group. Rumbak et al18 per- not find a significant difference in outcomes based on the
formed airway assessments via bronchoscopy at the time of tra- etiology of illness.
cheostomy or extubation and at 10 weeks postintubation. There
was a trend toward higher rates of late tracheal stenosis in the
early tracheostomy group compared with the late tracheostomy Discussion
group (68.3% vs 38.3%); however, this was not statistically sig- Our meta-analysis suggests that when performed within 7
nificant. Finally, Dunham and LaMonica16 assessed for laryngo- days, an early tracheostomy leads to a decreased length of
tracheal injury using flexible laryngoscopy following extubation ICU stay compared with late tracheostomy. No difference was
or decannulation. However, unlike the other 2 studies, they seen in hospital mortality. A pooled analysis could not be per-
assessed only patients who were symptomatic of upper airway formed for the incidence of pneumonia and length of mechani-
obstruction. They found early laryngotracheal injury in 17.6% cal ventilation secondary to significant heterogeneity. The
and 12.5% of the early and late tracheostomy groups, respec- incidence of pneumonia as well as the length of mechanical
tively. This difference was not significant. Outcomes regarding ventilation reported by the reviewed studies varied in direction,
late laryngotracheal injury were not reported. with some reporting a benefit while others reported a detriment
Liu et al 225

Table 4. Outcomes Based on Timing of Early Tracheostomy.


Incidence of Length of Mechanical Length of Hospital
Timing of Tracheostomy Pneumonia Ventilation ICU Stay Mortality

3 days18,22 RR = 0.38 — — RR = 0.77


95% CI = 0.13 to 1.16 95% CI = 0.29 to 2.03
I2 = 67% I2 = 71%
P = .09 P = .59
4-5 days16,19,20,23 RR = 1.03 WMD = 1.13 WMD = 22.09 RR = 0.97
95% CI = 0.92 to 1.15 95% CI = 24.45 to 6.71 95% CI = 25.91 to 1.73 95% CI = 0.83 to 1.13
I2 = 0% I2 = 91% I2 = 96% I2 = 0%
P = .58 P = .69 P = .28 P = .70
7-8 days15,17,21 RR = 0.87 — — RR = 0.81
95% CI = 0.64 to 1.19 95% CI = 0.61 to 1.06
I2 = 87% I2 = 0%
P = .37 P = .13
Abbreviations: CI, confidence interval; I2, I-squared statistic as a measure of heterogeneity; ICU, intensive care unit; RR, relative risk; WMD, weighted mean
difference; —, insufficient data for pooled analysis.

in the early tracheostomy group. Although the data regarding and length of ICU stay. The varying results may be attrib-
sedation use did not lend themselves to a meta-analysis, all 3 uted to certain methodological differences. Our protocol
studies examining this outcome found a significant decrease in excluded studies that compared early tracheostomy with
the early tracheostomy group.13,18,23 prolonged endotracheal intubation, whereas both Griffith
The risk of laryngotracheal injury is one of the chief con- et al and Wang et al included these studies in their overall
cerns for otolaryngologists when deciding to pursue to an analysis. This can be problematic because in the studies
early tracheostomy. Our systematic review found that there investigating early tracheostomy versus prolonged intubation,
were no significant differences in the occurrence of early or data regarding the number of patients requiring a late tra-
late injury based on the timing of tracheostomy.16,18,20 cheostomy, the day of late tracheostomy, and these patients’
However, the included studies had small sample sizes. As outcomes are often not explicitly stated. Therefore, it may be
such, there is a high risk of type II error in these studies, inappropriate to combine the outcomes from these studies with
whereby they were likely inadequately powered to detect those looking at early versus late tracheostomy, as they are
any true differences that might have existed between the measuring different treatment effects. Our meta-analysis also
treatment groups. Our finding of no difference may reflect included 4 additional trials that have been reported since the
the inadequacy of the current evidence rather than a true Wang et al study. Finally, we employed a more conservative
absence of benefit in performing an early tracheostomy. and rigorous approach in the statistical analysis and interpreta-
Another concern in deciding to perform an early tracheost- tion of our data. Specifically, we chose to forego pooled analy-
omy is whether it actually leads to higher rates of long-term ses for 2 of our outcomes due to significant heterogeneity. In
complications, such as tracheal stenosis, especially in both the Griffith et al and Wang et al studies, data were com-
patients who may not have needed to undergo the procedure bined for every outcome even when significant heterogeneity
because of successful later extubation. The results from was found (with the I2 statistic ranging from 58% to 87% in
Rumbak et al18 suggested a possible increase in late tracheal the Griffith et al study and 0% to 98% in the Wang et al
stenosis in the early tracheostomy group, albeit this differ- study). The following paragraph discusses the issue of combin-
ence was not significant. Therefore, at present, insufficient ing data in the presence of high statistical heterogeneity.
evidence exists to substantiate or dispute this concern. A common limitation encountered in meta-analyses,
Studies with longer term follow-up are needed to assess the including the present one, is the heterogeneity of the data.
true impact of an early tracheostomy on laryngotracheal out- Heterogeneity can result from both clinical variability of the
comes. This is an important issue that should be examined study populations as well as methodological variability from
in future investigations. the performance of the studies.12 In meta-analyses examin-
Our results differ from those of previous meta-analyses. ing the issue of early versus late tracheostomy, the major
Griffith et al24 did not find a significant difference in mor- sources of heterogeneity are the varying inclusion and
tality or pneumonia, but they did find a significant decrease exclusion criteria employed by each trial, the diverse patient
in the duration of mechanical ventilation and ICU length of populations, tracheostomy techniques, and particularly the
stay. A subsequent meta-analysis by Wang et al25 did not varied definitions of early and late tracheostomy. These var-
find a significant difference in any of the outcomes, includ- iations may result in more than one intervention effect. In
ing mortality, pneumonia, length of mechanical ventilation, this case, a pooled result would not be appropriate, as it
226 Otolaryngology–Head and Neck Surgery 152(2)

would not capture a real effect in any of the populations. In Author Contributions
our study, we decided to pool the data only if the heteroge-
neity was moderate or lower (I2  60%). The exception was C. Carrie Liu, conception of study, acquisition of data, data analy-
for ICU length of stay. We pooled the results for this out- sis, draft, revision and final approval of manuscript; Devon
Livingstone, acquisition of data, revision and final approval of
come as the measured effects from each study were in the
manuscript; Elijah Dixon, acquisition of data, revision and final
same direction, favoring early tracheostomy. In this case,
approval of manuscript; Joseph C. Dort, conception of study,
the true effect likely lies in that direction, and we felt that a acquisition of data, revision and final approval of manuscript.
pooled analysis would best capture this.
A second limitation of our study is that we may not have Disclosures
included all randomized and quasi-randomized trials com- Competing interests: None.
paring the outcomes of early tracheostomy with late tra- Sponsorships: None.
cheostomy. We performed a thorough search and minimized Funding source: None.
the chance of missing relevant studies by having an inclu-
sive search strategy performed systematically by two References
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