Langenbeck's Archives of Surgery (2018) 403:137–149

https://doi.org/10.1007/s00423-017-1648-8

SYSTEMATIC REVIEWS AND META-ANALYSES

Percutaneous versus surgical strategy for tracheostomy: a systematic

review and meta-analysis of perioperative and postoperative
complications
Rosa Klotz 1,2 & Pascal Probst 1,2 & Marlene Deininger 3 & Ulla Klaiber 1,2 & Kathrin Grummich 1 & Markus K. Diener 1,2 &
Markus A. Weigand 4 & Markus W. Büchler 2 & Phillip Knebel 1,2

Received: 1 August 2017 / Accepted: 17 December 2017 / Published online: 27 December 2017
# Springer-Verlag GmbH Germany, part of Springer Nature 2017

Abstract
Purpose Tracheostomy is one of the most frequently performed procedures in intensive care medicine. The two main approaches are
open surgical tracheostomy (ST) and percutaneous dilatational tracheostomy (PDT). This systematic review summarizes and analyzes
the existing evidence regarding perioperative and postoperative parameters of safety.
Methods A systematic literature search was conducted in the Cochrane Library, EMBASE, LILACS, and MEDLINE to identify all
randomized controlled trials (RCTs) comparing complications of ST and PDT and to define the strategy with the lower risk of
potentially life-threatening events. Risk of bias was assessed using the criteria outlined in the Cochrane Handbook.
Results Twenty-four citations comprising 1795 procedures (PDT: n = 926; ST: n = 869) were found suitable for systematic review. No
significant difference in the risk of a potentially life-threatening event (risk difference (RD) 0.01, 95% CI − 0.03 to 0.05, P = 0.62, I2 =
47%) was found between PDT and ST. There was no difference in mortality (RD − 0.00, 95% CI − 0.01 to 0.01, P = 0.88, I2 = 0%). An
increased rate of technical difficulties was shown for PDT (RD 0.04, 95% CI 0.01, 0.08, P = 0.01, I2 = 60%). Stomal infection occurred
more often with ST (RD − 0.05, 95% CI − 0.08 to − 0.02, P = 0.003, I2 = 60%). Both techniques can be safely performed on the ICU.
Meta-analysis of the duration of procedure was not possible owing to high heterogeneity (I2 = 99%).
Conclusion ST and PDT are safe techniques with low incidence of complications. Both techniques can be performed successfully in an
ICU setting. ST can be performed on every patient whereas PDT is restricted by several contraindications like abnormal anatomy,
previous surgery, coagulopathies, or difficult airway of the patient.
Systematic review registration PROSPERO CRD42015021967

Electronic supplementary material The online version of this article

(https://doi.org/10.1007/s00423-017-1648-8) contains supplementary
material, which is available to authorized users.

* Rosa Klotz Markus W. Büchler

rosa.klotz@med.uni-heidelberg.de markus.buechler@med.uni-heidelberg.de
Phillip Knebel
Pascal Probst
phillip.knebel@med.uni-heidelberg.de
pascal.probst@med.uni-heidelberg.de
Marlene Deininger 1
Study Center of the German Surgical Society (SDGC), University of
marlene.deininger@klinikum-graz.at Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany
2
Ulla Klaiber Department of General, Visceral and Transplantation Surgery,
ulla.klaiber@med.uni-heidelberg.de University of Heidelberg, Im Neuenheimer Feld 110,
69120 Heidelberg, Germany
Kathrin Grummich
3
KGrummich@web.de Department of Anaesthesiology and Intensive Care Medicine,
Division of General Anaesthesiology, Emergency- and Intensive
Markus K. Diener Care Medicine, University Hospital Graz, Medical University of
markus.diener@med.uni-heidelberg.de Graz, Auenbruggerplatz 29, 8036 Graz, Austria
4
Markus A. Weigand Department of Anesthesiology, University of Heidelberg, Im
markus.weigand@med.uni-heidelberg.de Neuenheimer Feld 110, 69120 Heidelberg, Germany
138
Keywords Tracheostomy . Percutaneous dilatational tracheostomy . Surgical tracheostomy . Systematic review with meta-analysis
Introduction
Tracheostomy is one of the most frequently performed proce-
dures in intensive care medicine [1, 2]. In 2014, 53,200 such
operations were performed in Germany [3]. Tracheostomy is
considered to be a safe technique to achieve adequate ventilation
for patients who suffer from an obstruction of the upper airway or
need long-term ventilation [4]. Furthermore, tracheostomy facil-
itates early weaning from the ventilation according to an
established standardized weaning protocol [5].
Two different strategies are available for formation of a
tracheostoma: open surgical tracheostomy (ST), first described
in 1909, and predominantly performed by surgeons [6], and the
interventional strategy of percutaneous dilatational tracheostomy
(PDT), initially described in 1985 and performed by surgeons,
internists, and anesthetists [7]. For PDT, six different commonly
performed techniques can be distinguished: balloon dilation tra-
cheostomy (BDT) [8], guidewire dilating forceps tracheostomy
(GWT) [9], multiple dilator tracheostomy (MDT) [7], rotational
dilation tracheostomy (RDT) [10], single-step dilation tracheos-
tomy (SSDT) [11], and translaryngeal tracheostomy (TLT) [12].
Both strategies bear advantages and disadvantages. Rare but
dangerous perioperative complications of both strategies which
can compromise the airway include loss of airway [13],
paratracheal insertion [14], tracheal or esophageal laceration
[15], hemorrhage [16], pneumothorax [17], subcutaneous em-
physema [18], and technical difficulties [19]. Typical late com-
plications that can occur with both strategies are tracheal stenosis,
tracheal fistula, and tracheomalacia [20, 21]. For PDT, additional
important contraindications already exist, e.g., previous tracheos-
tomies, neck anomalies, unfavorable anatomy, untreatable coag-
ulopathies, or emergency tracheostomies.
Stoma inflammation and infection tend to be rarer with
PDT [22, 23] than with ST. On the other hand, with ST, the
newly established access to the airway is immediately secured
by cutting a small square of tissue from the tracheal cartilage
and suturing it to the skin. In contrast, the PDT is performed
via a small skin incision followed by one of various dilatation-
al procedures and insertion of the tracheal cannula. In the case
of accidental dislocation of the tracheal cannula, reintubation
via the same access might be more difficult [24]. Safe venti-
lation might become impossible, a life-threatening situation
[25]. However, time, effort, inconvenience [26], and the need
to transport critically ill patients to the operation room (OR)
(not necessary for PDT) have all been advanced as arguments
against ST [27].
Consequently, there is disagreement on which strategy of-
fers the superior benefit/risk ratio for critically ill patients.
Previously published meta-analyses reported conflicting
Langenbecks Arch Surg (2018) 403:137–149
results [2, 19, 28–31], and it must be pointed out that some
older reviews did not include the currently available percuta-
neous techniques. None of the existing reviews succeeded in
including all relevant randomized controlled trials (RCTs).
The most recent review resulted in low-quality evidence of a
non-significant advantage for PDTs in terms of mortality and
the rate of serious adverse events [31]. To date, the choice of
strategy depends primarily on the intensive care team’s pref-
erence and not on evidence, as the evidence concerning which
strategy is safer is poor and conflicting.
Our objective was to determine whether ST is superior to
PDT in adult critically ill patients with respect to the patient-
relevant outcome of potentially life-threatening events during
or after the procedure, including all relevant RCTs.
Furthermore, mortality, duration of the procedure, technical
difficulties, stoma inflammation and infection, and late com-
plications were compared.
Material and methods
The protocol of this study has been registered in the
PROSPERO international prospective register of systematic
reviews [32]. It was written according to the Preferred
Reporting Items for Systematic Reviews and Meta-Analysis
Protocols 2015 (PRISMA-P 2015) [33] and published open
access [34]. The PRISMA 2009 checklist was used for
reporting of this systematic review [35].
Systematic literature search methodology
A systematic literature search was conducted to identify all
relevant RCTs comparing ST and PDT. To achieve the highest
possible level of evidence, this systematic review and propor-
tional meta-analysis includes RCTs only. The databases
Cochrane Library (CENTRAL), EMBASE, LILACS, and
PubMed/MEDLINE were searched for RCTs published up
to June 12, 2016. A complete list of search terms can be found
in additional file 1. The clinical trials registry ClinicalTrials.
gov was also searched to identify any relevant unpublished or
ongoing trials. Furthermore, experts in the field were asked
whether they knew of further relevant trials. Both published
and unpublished RCTs were searched, and no language
restrictions were applied. Publications in languages other
than English were included and translated. All articles were
entered into a library in the reference software program
EndNote (EndNote X7, Philadelphia).
Langenbecks Arch Surg (2018) 403:137–149 139

Trial selection

Two of the authors independently screened all identified trials

for eligibility. The full selection process is described in our
protocol publication [34]. The selection process can be
retraced in detail in the PRISMA flow diagram (Fig. 1). We
restricted the search to RCTs investigating tracheostomy in
adult critically ill patients. Trials assessing tracheostomy in
emergency airway management or in children were excluded
to minimize heterogeneity.

Data extraction and management

A standardized data collection form was used for extraction of

trial characteristics and outcome data. Trial characteristics ad-
dressing methods, participants, interventions, and outcomes of
all trials were extracted by two authors independently as pre-
viously described in our protocol publication [34].

Endpoints

The composite primary endpoint of this study was the risk of

potentially life-threatening events, including loss of airway,
false route, tracheal/esophageal injury, major bleeding, pneu-
mothorax/-mediastinum, subcutaneous emphysema, gastric
aspiration, difficult tube exchange, and others. All potentially
life-threatening events were added to calculate the composite
endpoint. No more than one potentially life-threatening event
was counted for each procedure. Moreover, mortality assumed
to be directly related to the intervention was assessed.
Furthermore, complications such as technical difficulties, sto-
mal infection, stomal inflammation, and late complications
were evaluated separately, as was the duration of the proce-
dure. Subgroup analyses were carried out in order to analyze
superiority of individual PDT techniques, concomitant diag-
nostic procedures (bronchoscopy/ultrasound), specialty and
experience of the performing physician, and the setting (OR/ Fig. 1 Study flow diagram
intensive care unit) of tracheostomy as described in detail in
our protocol publication [34].
Statistical analysis
Assessment of methodological quality of included
trials Dichotomous data were analyzed in terms of absolute differ-
ence with 95% confidence interval and continuous data as
The risk of bias was assessed for each trial using the criteria mean difference. Meta-analyses were performed only where
outlined in the Cochrane Handbook for Systematic Reviews meaningful, i.e., if the treatments, the participants, and the
of Interventions [36] and as described in our protocol publi- underlying clinical question were similar enough to justify
cation [34]. The quality of the body of evidence was addressed pooling.
using the specific evidence grading system developed by the In the case of continuous data, means and standard devia-
GRADE working group. The following five aspects were con- tions are reported. For trials where medians and interquartile
sidered: limitations in design, indirectness of evidence, unex- ranges had been reported, means and standard deviations were
plained heterogeneity or inconsistency of results, imprecision calculated using the methods described by Higgins and Green
of results, and high probability of publication bias [37]. in 2011 [36] and by Hozo et al. in 2005 [38]. The decision
140
whether to perform quantitative synthesis of these data was
taken individually for each outcome.
To assess the robustness of our conclusions, we conducted
sensitivity analyses excluding trials with fewer than the aver-
age number of positive judgments in the risk of bias assess-
ment. The review was conducted according to the published
protocol [34], and any deviations from it are reported below
under the BDifferences between protocol and review^ section.
Assessment of heterogeneity
I2 statistics was used to measure statistical heterogeneity
among the trials in each analysis. An I2 < 25% was considered
as low heterogeneity, I2 > 75% as high heterogeneity. If het-
erogeneity was extreme, summary effect measures were
interpreted with caution. Clinical heterogeneity was explored
by assessing differences in baseline data, performers’ disci-
pline, type of percutaneous technique, definitions of outcome
parameters, and operative and/or perioperative management.
The presence of strong clinical heterogeneity was a factor in
the decision whether to conduct quantitative synthesis of data
or to perform sensitivity analyses with a special focus.
Trial authors were asked to provide missing outcome data
if this was necessary. Where this was not possible, and the
missing data were thought to introduce serious bias, the im-
pact of including such trials in the overall assessment of results
was explored by means of sensitivity analysis. A funnel plot
was created and examined for asymmetry to explore possible
publication bias.
Differences between protocol and review
The exact definition of mortality was changed from protocol
to analysis. Whenever trial authors declared a correlation be-
tween intervention and death of a patient we adopted this for
our meta-analysis, regardless of when death occurred. No time
limit was imposed for the review, whereas the protocol had
foreseen limitation to the first 24 h after intervention.
Results
Excluded trials
The systematic literature search yielded 203 abstracts. Of
these, 48 were excluded as duplicates during the screening
process. On screening of the remaining 155 full articles, 125
were excluded: 90 covered other topics and 35 were not RCTs.
Thus, 30 RCTs [14, 20–25, 39–61] were potentially eligible.
Further, six had to be excluded:
The publications by Muttini et al. in 1999 [49] and Melloni
et al. in 2002 [48], and those by Lukas et al. in 2006 [60] and
2007 [21], presented results from the same patient samples;
Langenbecks Arch Surg (2018) 403:137–149
therefore, each set of data was included only once. The data of
the trials by Raine et al. in 1999 [51] and Stoeckli et al. in 1997
[54] could not be included in the quantitative and qualitative
analysis because only congress abstracts were available. The
trial by Chen et al. in 2008 [59] could not be retrieved from the
Cochrane library or elsewhere. Finally, the trial by Stocchetti
et al. in 2000 [53] was excluded because our endpoints were
not adequately assessed.
Included trials
Following the above-described exclusion process, the quanti-
tative data of the remaining 24 trials with 1795 analyzed pro-
cedures comparing PDT (926 procedures) and ST (869 proce-
dures) were deemed suitable for the systematic review
(Fig. 1).
The characteristics of the RCTs included in our analysis are
shown in Table 1. All trials were single-center trials, with a
mean recruitment period of 26 months. The trials came from
North America, Europe, Asia, Africa, Australia, and South
America. The recruitment period varied from 9 to 47 months.
Sample sizes varied considerably (range, 16 [55] to 205 [21])
but the intra- and interstudy population baseline characteris-
tics were comparable. Out of six different commonly per-
formed techniques of PDT in the included trials, only four
were performed: MDT (n = 15) [14, 23–25, 39–42, 44,
46–48, 50, 52, 57]; GWT (n = 5) [21, 22, 45, 55, 61], SSDT
(n = 3) [43, 56, 58], and TLT (n = 1) [20]. There was hetero-
geneity regarding the use of bronchoscopy as shown in
Table 1; however, in more than half of the included trials
(n = 13) [14, 20, 24, 25, 39, 41, 46–48, 50, 52, 56, 58], bron-
choscopy was carried out during PDT to visualize and control
the entry into and dilation of the trachea. Also, the location
where PDT and ST were performed (OR versus ICU) differed
among the included trials (see Table 1).
In all trials, defined exclusion criteria for patients such as
refractory coagulopathy, abdormal or difficult anatomy (goi-
ter, neck masses, previous neck surgery, difficult landmarks,
inflammation at the tracheostomy site…), difficult airway for
translaryngeal intubation, emergency situations, hemodynam-
ic instability, invasive ventilation with high positive end-
expiratory pressure, and others were defined (see Table 1).
Risk of bias in included trials
The risk of bias tool of the Cochrane handbook was used for
critical appraisal. It revealed heterogeneity in the design of the
included trials. Only in four trials was sample size calculation
performed at all [20, 22, 52, 58]. In these trials, the underlying
expected difference in incidence of complications varied dis-
tinctly between the ST group (30–50%) and the PDT group
(6–35%), thus resulting in planned sample sizes of 64 [22] to
370 [52] patients per group.
Langenbecks Arch Surg (2018) 403:137–149 141

Table 1 Characteristics of included trials

First Country No. of Specialty of primary Method Location of Sample size Bronchoscopic Frequent exclusion criteria
author and procedures investigator of PDT tracheostomy calculation guidance
year

Ahn 1998 Korea 38 Internal medicine MDT ICU/ICU No Yes Difficult anatomy, emergency,
previous tracheotomy
Antonelli Italy 139 Anesthesiology TLT ICU/OR Yes Yes Coagulopathy, difficult
2005 anatomy, emergency,
previous
tracheostomy
Celedon Chile 50 Otolaryngology— MDT OR/OR No Yes Coagulopathy, difficult
2007 head and neck anatomy, hemodynamic
surgery instability
Croft 1995 Canada 53 Anesthesiology MDT ICU/OR No No Coagulopathy, difficult
anatomy
Freeman USA 80 Surgery MDT ICU/OR No Yes Coagulopathy, difficult
2001 anatomy, difficult
translaryngeal
intubation, high positive
end-expiratory pressure
Friedman USA 53 Intensive care MDT ICU/OR No No Coagulopathy, difficult
1996 medicine anatomy, hemodynamic
instability, high positive
end-expiratory pressure,
previous tracheostomy
Gysin Switzerland 70 Otolaryngology— MDT Both/both No Yes Previous tracheostomy
1999 head and neck
surgery
Hasanloei Iran 60 Anesthesiology SSDT ICU/OR No No Coagulopathy, difficult
2014 anatomy, difficult
translaryngeal
intubation, emergency, high
positive end-expiratory
pressure
Hazard USA 48 Internal medicine MDT ICU/both No No Coagulopathy, difficult
1991 anatomy
Heikkinen Finnland 57 Surgery GWT ICU/ICU No No Difficult anatomy, previous
2000 tracheostomy
Holdgaard Denmark 60 Anesthesiology MDT OR/OR No No Coagulopathy, difficult
1998 anatomy, previous
tracheostomy
Kaylie USA 24 Otolaryngology— MDT ICU/ICU No Yes Difficult anatomy,
2003 head and neck hemodynamic instability,
surgery high
positive end-expiratory
pressure
Kumar India 32 Otolaryngology— MDT ICU/ICU No Yes Coagulopathy, difficult
2005 head and neck anatomy
surgery
Lukas Czech 205 Otolaryngology— GWT ICU/ICU No No Coagulopathy, difficult
2007 Republic head and neck anatomy, high positive
surgery end-expiratory pressure,
previous tracheostomy
Massick USA 100 Otolaryngology— MDT ICU/ICU No Yes Coagulopathy, difficult
2001 head and neck anatomy, difficult
surgery translaryngeal intubation,
emergency, high
positive end-expiratory
pressure
Italy 50 Thoracic surgery MDT ICU/both No Yes
142 Langenbecks Arch Surg (2018) 403:137–149

Table 1 (continued)

First Country No. of Specialty of primary Method Location of Sample size Bronchoscopic Frequent exclusion criteria
author and procedures investigator of PDT tracheostomy calculation guidance
year

Melloni Coagulopathy, difficult

2002 anatomy, previous
tracheostomy
Porter USA 24 Surgery MDT ICUICU No Yes Coagulopathy, difficult
1996 translaryngeal intubation,
emergency
Silvester Australia 200 Intensive care MDT ICU/ICU Yes Yes Coagulopathy, difficult
2006 medicine anatomy, previous
tracheostomy
Sustic Croatia 16 Anesthesiology GWT ICU/OR No No Coagulopathy
2002
Tabaee USA 43 Otolaryngology— SSDT ICU/ICU No Yes Coagulopathy, difficult
2005 head and neck anatomy, difficult
surgery translaryngeal intubation,
emergency, high
end-expiratory pressure,
previous tracheotomy
Wu 2003 Taiwan 83 Emergency medicine MDT ICU/OR No Yes/no Coagulopathy, difficult
anatomy, emergency,
previous
tracheostomy
Xu 2007 China 166 Intensive care GWT ns No Yes and no Coagulopathy, difficult
medicine (two PDT anatomy
groups)
Yaghoobi Iran 80 Anesthesiology SSDT ICU/OR Yes Yes Coagulopathy, difficult
2014 anatomy, difficult
translaryngeal intubation,
hemodynamic instability,
previous tracheostomy
Youssef Egypt 64 Otolaryngology— GWT ns Yes ns Coagulopathy, difficult
2011 head and neck anatomy, previous
surgery tracheostomy

MDT multiple dilator tracheostomy, ICU intensive care unit, TLT translaryngeal tracheostomy, OR operating room, GWT guidewire dilating forceps
tracheostomy, SSDT single-step dilation tracheostomy, ns not stated

Statistical analysis was performed according to the
intention-to-treat principle in 23 trials and per protocol in
one trial [57]. A randomization process was described correct-
ly in 15 trials. In the remaining nine trials, randomization
process was not performed or described adequately.
In four trials, patients were blinded to the intervention [14,
20, 23, 39], and in three trials, the outcome assessors were
masked [14, 20, 52]. No masking was attempted in any of
the other trials. Overall, the impact of a masked observer or
patient on the reduction of bias would be marginal, because
the endpoint Bpotentially life-threatening event^ is objective
and leaves little room for interpretation. Attrition bias for our
primary endpoint was assessed as low in 12 trials. In these
trials, length of follow-up was described adequately varying
from 1 week to 48 months. For the 12 trials without a descrip-
tion of follow-up and study visits, attrition bias was assessed
as unclear. Youssef and colleagues [22] published their study
protocol retrospectively. No other study protocols were pub-
lished. However, the risk of reporting bias was judged as low
for all included trials, on the assumption that potentially life-
threatening events were reported by all authors.
The sources of bias are summarized in Fig. 2.
Endpoints
Potentially life-threatening events
There was no significant difference in the risk of poten-
tially life-threatening events (risk difference (RD) 0.01,
95% CI − 0.03 to 0.04, P = 0.67, I2 = 47%) between the
Langenbecks Arch Surg (2018) 403:137–149 143

ƒFig. 2 Risk of bias summary

PDT group (81 events in 926 procedures; 8.7%) and the

ST group (64 events in 869 procedures; 7.4%) (Fig. 3).
A funnel plot was generated for this outcome and no pub-
lication bias was found (Fig. 4). Subgroup analyses for all
different techniques of PDT were performed but also showed
no significant differences compared to ST.
A sensitivity analysis excluding trials with fewer than the
average number of positive judgments in the risk of bias as-
sessment showed no change in the overall effect results.
There was no significant difference between ST and any
kind of PDT in the risk of the single endpoints loss of airway,
false route, tracheal/esophageal injury, major bleeding, pneu-
mothorax/-mediastinum, subcutaneous emphysema, gastric
aspiration, or other potentially life-threatening events.

Technical difficulties

There was an increased rate of technical difficulties with PDT

(52 events in 716 procedures; 7.3%) compared to ST (12
events in 653 procedures; 1.8%; RD 0.04, 95% CI 0.01,
0.08, P = 0.01, I2 = 60%) (Fig. 5). Twelve cases in the PDT
group had to be converted to ST because of technical difficul-
ties (1.7%).

Mortality

There was no significant difference in procedure-related

mortality (RD − 0.00, 95% CI − 0.01 to 0.01, P = 0.88,
I 2 = 0%) between PDT (3 events in 926 procedures;
0.3%) and ST (6 events in of 869 procedures; 0.7%).
Subgroup analyses for the different techniques of PDT
(MDT, GWT, SSDT) also revealed no significant differ-
ence in mortality between PDT and ST.

Duration of procedure

The duration of the tracheostomy procedure revealed vast

heterogeneity (I 2 = 99%). The mean duration of PDT
varies from 4 to 32 min and that of ST from 9 to
44 min. To reduce heterogeneity, we performed a sub-
group analysis including only those 15 trials with the
same clearly described definition of duration (from inci-
sion to tube placement), but heterogeneity was still very
high (I2 = 96%). Thus, summary effect measures could
not be interpreted adequately.

Stomal infection and inflammation

Stomal inflammation and infection occurred significantly

more often with ST (inflammation, 48 events in 216
144 Langenbecks Arch Surg (2018) 403:137–149

Fig. 3 Forest plot of potentially life-threatening events

procedures; 22.2%; infection, 52 events in 681 procedures;
7.6%) than with PDT (inflammation, 17 events in 286 proce-
dures; 5.9%; infection, 10 events in 724 procedures; 1.4%)(in-
flammation: RD − 0.16, 95% CI − 0.28 to − 0.04, P = 0.007,
I2 = 73%; infection: RD − 0.05, 95% CI − 0.08 to − 0.02, P =
0.003, I2 = 60%) (Fig. 6).
Location where tracheostomy was performed
In nine trials, all tracheostomies were performed on the ICU.
In eight trials, PDT was performed on the ICU and ST in the
OR. In three trials, tracheostomy was performed on the ICU or
OR, and in two trials, both techniques were performed in the

Fig. 4 Funnel plot of the PDT

versus ST with the outcome
potentially life-threatening event
Langenbecks Arch Surg (2018) 403:137–149
Fig. 5 Forest plot of technical difficulties
OR. However, when both techniques were performed at the
bedside on the ICU, there was a tendency favoring ST with
regard to potentially life-threatening events (RD 0.05, 95% CI
− 0.01 to 0.10, P = 0.08, I2 = 39%).
Bronchoscopic control
The subgroup analysis for trials using bronchoscopic
control for PDT (n = 14) [14, 20, 24, 25, 39, 41,
Fig. 6 Forest plot of stomal infection
145
46–48, 50, 52, 56, 58, 61] versus ST and no broncho-
scopic control versus ST (n = 9) [21–23, 40, 42–45, 61]
revealed no significant differences in the frequency of
occurrence of potentially life-threatening events. The tri-
al by Xu et al. [61] was included in both groups be-
cause the PDT group was divided into two arms, one
with and the other one without bronchoscopic control.
According to this data, bronchoscopy tends to decrease
the safety of PDT (Fig. 7).
146
Fig. 7 Forest plot of potentially life-threatening events with and without bronchoscopy
Late complications
There was no difference between ST and any kind of PDT in late
complications, including tracheal stenosis, tracheomalacia, and
tracheocutaneous/esophageal fistula (RD − 0.01, 95% CI −
0.06 to 0.03, P = 0.51, I2 = 32%).
Discussion
The potential risks and related complications of tracheostomy in
adult critically ill patients, whether performed as an open surgical
or percutaneous dilatational procedure, have been debated exten-
sively in recent years. Several RCTs and non-randomized studies
of available techniques have been carried out, but most of them
were impaired by major methodological flaws. Analyzing the
whole available evidence so far, results are still inconclusive.
Langenbecks Arch Surg (2018) 403:137–149
Furthermore, six meta-analyses [2, 19, 28, 29, 31, 62] of the best
strategy for tracheostomy already exist but none of them was able
to cover all existing evidence. Even in the latest, four trials [24,
46, 47, 58] with more than 160 patients are missing.
This meta-analysis covers the first time all available pa-
tients from 24 existing randomized controlled trials with a
total of 1795 analyzed procedures. This is the largest pub-
lished sample size including exclusively RCTs.
The composite endpoint Bpotentially life-threatening events^
is the most patient-relevant and comprehensive endpoint to com-
pare the safety of the two techniques of tracheostomy.
Addressing only several individual complications of the interven-
tion separately provides no satisfactory answer to the critical
question of superiority in terms of security. A similar definition
of Bpotentially life-threatening event^ was only used by the
meta-analysis by Brass et al. but differed in some important
aspects. Only major bleeding, tracheal or esophageal injury, loss
Langenbecks Arch Surg (2018) 403:137–149
of airway, and misplaced airway were counted as life-threatening
events. Pneumothorax/pneumomediastinum, subcutaneous em-
physema, and gastric aspiration were not considered.
Our meta-analysis shows no significant difference between
ST and PDT in the risk of potentially life-threatening events or
mortality.
PDT is associated with significantly increased technical
difficulties which led to an intraprocedural switch to the open
strategy in 12 of 52 cases. On the other hand, PDT reduces
significantly stoma inflammation and infection, which is in
line with previous available meta-analyses [2, 19, 62].
However, clinical relevance of tracheostoma infections needs
to be discussed since severity of infections and negative im-
pact for patients is not addressed in detail in any of the includ-
ed trials.
Although previous meta-analyses had claimed that PDT
takes less time to perform than ST [2, 19, 29, 62], we refrain
to make definite statements or recommendations due to the
enormous heterogeneity observed. Thus, mean duration of
PDT varies from 4 min [44] to 32 min [24] and that of ST
from 9 min [43] to 44 min [47], which may be partly due to
imprecise or missing definitions of this endpoint. In this case,
a quantitative aggregation in terms of meta-analysis is not
reasonable.
The location where tracheostomy was performed (ICU ver-
sus OR) had no significant impact on the risk of potentially
life-threatening events. Thus, ST can be safely performed on
the ICU and transport to the OR is not necessary.
Surprisingly, our data could not show an increase in safety
when performing bronchoscopic visual control during PDT.
However, this needs to be interpreted with caution, as bron-
choscopy is the standard tool for PDT and according to clin-
ical experience judged a valuable adjunct to improve safety
and effectiveness of PDT. Nevertheless, it is not without risk,
since insertion of the bronchoscope into the airway potentially
leads to hypoventilation, hypercarbia, and a rise in intracranial
pressure [63, 64].
Of note, all here presented results refer to uncomplicated
standard tracheostomy. For complicated tracheostomy like in
emergency situations or patients with coagulopathies, neck
anomalies, or previous tracheostomy, there is already a con-
sensus that all these cases are routed to ST in daily practice.
These patients were excluded in most analyzed trials, as
shown in Table 1.
The following limitations have to be taken into consider-
ation: The variation in definition of the complications may
have caused detection bias. More bias might be caused by
significant flaws in the baseline methodology of analyzed pri-
mary trials restraining the level of evidence of this meta-anal-
ysis. Ten of the 24 included RCTs failed either to describe or
to perform randomization adequately. Moreover, maintenance
of allocation concealment was not satisfactory described or
achieved in 14 trials. Both of these factors can be considered
147
a source of selection bias. Blinding of patients and outcome
assessors was not performed in most of the included trials, but
performance bias and detection bias are judged as marginal
because the endpoint Bpotentially life-threatening event^ is
objective and leaves little room for interpretation. However,
the assessment of whether a described event constitutes a po-
tentially life-threatening event introduces a potential source of
bias.
Timing and frequency of follow-up were not described
sufficiently and differed between trials; for the primary end-
point, however, the immediate postoperative period seems to
be the most relevant time, so that severe attrition bias does not
have to be suspected. Only the endpoint Bloss of airway^
depends on a proper follow-up, since loss of airway typically
occurs when accidental decannulation happens or when the
first planned tube change takes place. In clinical practice, this
complication seems more critical with PDT than with ST. To
answer this question, a large multicenter RCT would be need-
ed. In such an RCT, accidental decannulation during the first
few days after the procedure, up to the time of the first tube
change, should be especially taken into account and included
in the composite endpoint of potentially life-threatening
events. Clear definitions and close follow-up would be need-
ed. On the basis of our sensitivity analysis data, however, a
sample size of 864 patients would be required to have an 80%
chance of detecting; at the 5% level of significance, an in-
crease in the primary outcome measure from 5% in the control
group to 10% in the experimental group.
Conclusion
ST and PDT are safe techniques with low incidence of com-
plications. Though both techniques can be performed success-
fully in an ICU setting, ST has the advantage that it can be
performed in all patients whereas PDT is restricted by several
contraindications. A difference in the risk of potentially life-
threatening events could only be explored further with a high-
quality multicenter RCT.
Authors’ contributions MAW, MKD, MWB, PK, and RK designed the
study. KG, MD, RK, and UK acquired the data; PK, PP, and RK analyzed
and interpreted the data. MKD, PK, and RK drafted the manuscript. All
authors critically revised the manuscript.
Funding This work was funded by a grant from the Heidelberger Stiftung
Chirurgie (https://www.stiftung-chirurgie.de/startseite.html).
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
Ethical approval This article does not contain any studies with human
participants performed by any of the authors.
148
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