Systematic Review
Otolaryngology–
Early versus Late Tracheostomy: A
Systematic Review and Meta-Analysis
C. Carrie Liu, MD1, Devon Livingstone, MD1,
Elijah Dixon, MD, MSc2, and Joseph C. Dort, MD, MSc1,3
No sponsorships or competing interests have been disclosed for this article.
Abstract
Objective. To investigate whether early tracheostomy leads
to improved outcomes compared with late tracheostomy.
Data Sources. Ovid MEDLINE (including PubMed), Embase,
and the Cochrane Central Register of Controlled Trials.
Review Methods. A systematic search was performed of the
above-mentioned databases according to PRISMA guide-
lines. Data were collected on the following outcomes of
interest: hospital mortality, intensive care unit length of
stay, length of mechanical ventilation, incidence of pneu-
monia, laryngotracheal injury, and sedation use. Analysis
was performed using the RevMan 5 software (Cochrane
Collaboration, Oxford, England).
Results. Eleven studies were included for analysis. There was a
significant decrease in the intensive care unit length of stay in
the early tracheostomy group (weighted mean difference,
29.13 days; 95% confidence interval [CI], 217.55 to
20.70; P = .03). There was no significant difference in hos-
pital mortality (relative risk, 0.84; 95% CI, 0.67 to 1.04; P =
.11). A pooled analysis was not performed for the incidence
of pneumonia or length of mechanical ventilation, secondary
to considerable heterogeneity among the studies. None of
the studies reporting laryngotracheal outcomes found a signif-
icant difference between the early and late tracheostomy
groups, whereas all 3 studies reporting sedation use found a
significant decrease in the early tracheostomy group.
Conclusion. Early tracheostomy performed within 7 days of intuba-
tion was associated with a decrease in intensive care unit length of
stay. No difference was found in hospital mortality. Insufficient data
currently exist to make conclusions about the effect of early tra-
cheostomy on the incidence of pneumonia, length of mechanical
ventilation, laryngotracheal injury, or sedation use.
Keywords
tracheostomy, tracheotomy, prolonged intubation, systema-
tic review, meta-analysis
Received July 8, 2014; revised October 13, 2014; accepted November
6, 2014.
Head and Neck Surgery
2015, Vol. 152(2) 219–227
Ó American Academy of
Otolaryngology—Head and Neck
Surgery Foundation 2014
Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/0194599814561606
http://otojournal.org
T
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-
longed intubation and ventilation.2 Compared with endotracheal
intubation, the proposed advantages of tracheostomy are that it
facilitates weaning from mechanical ventilation, allows for
quicker resumption of speech and oral intake, and is more com-
fortable for the patient.1-4 Another proposed advantage of tra-
cheostomy is that there is a lower risk of laryngeal injury. Rates
of early laryngeal injury following endotracheal intubation have
been reported to be as high as 94%.5 Long-term sequelae such
as granulomas and laryngeal stenosis range from 5% to 12%,5,6
with increased length of endotracheal intubation associated with
a higher incidence of stenosis.6 With the development of more
flexible tubes with low-pressure cuffs and improved tube man-
agement strategies, laryngeal injury and the related sequelae are
less common.4 Laryngeal injury, however, remains an important
risk as the course of intubation lengthens.7
The optimal timing of tracheostomy in critically ill patients
requiring prolonged mechanical ventilation is debated.
Convention dictates that a tracheostomy may be performed if
the course of mechanical ventilation exceeds 14 days.7 A con-
sensus conference held in 1989 stated that patients who require
mechanical ventilation for up to 10 days may be endotrache-
ally intubated, whereas tracheostomy is favored if mechanical
ventilation is predicted to be greater than 21 days.2 The evi-
dence for this, however, is limited and a defined pathway for
1
Division of Otolaryngology–Head and Neck Surgery, Department of
Surgery, University of Calgary, Alberta, Canada
2
Division of General Surgery, Department of Surgery, University of Calgary,
Alberta, Canada
3
Ohlson Research Initiative, University of Calgary, Alberta, Canada
This article was presented at the 2014 AAO-HNSF Annual Meeting & OTO
EXPO; September 21-24, 2014; Orlando, Florida.
Corresponding Author:
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.
Email: jdort@ucalgary.ca
A podcast for this article is available at
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220
the management of the airway in this population of patients
does not exist.7,8
Our goal in this study is to perform a systematic review
and meta-analysis of existing literature, investigating whether
early tracheostomy leads to improved outcomes compared
with late tracheostomy in critically ill patients.
Methods
Search Strategy and Study Selection
A systematic search was performed according to PRISMA
(Preferred Reporting Items for Systematic Reviews and
Meta-Analyses) guidelines by 2 reviewers (C.C.L. and D.L.).
The MEDLINE (including PubMed) and Embase databases
were searched using key terms tracheo$ and intubation,
whereby the symbol $ denotes the inclusion of all variations
of the term beginning with the stem tracheo (ie, to include
both tracheostomy and tracheotomy). The search terms tra-
cheo$ and intubation were each cross-searched with the
MeSH term time factors to identify studies that examine the
timing of tracheostomy and intubation. The Cochrane Central
Register of Controlled Trials (CENTRAL) database was also
searched using the key words tracheostomy and tracheotomy.
Studies were limited to those published over the past 30
years (January 1, 1983, through September 1, 2013), in the
English language, and involving human subjects. The biblio-
graphies of relevant studies were hand-searched to identify
any additional studies.
Title and abstract review was performed once the initial list
of studies was generated. The reviewers met prior to commen-
cing study selection to ensure consistency in the application of
the inclusion criteria. Studies were selected if they met the 4
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
study examined the outcomes of early tracheostomy compared
with late tracheostomy, and (4) the outcomes included at least
one of the following: hospital mortality, length of intensive
care unit (ICU) stay, length of mechanical ventilation, inci-
dence of pneumonia, laryngotracheal injury, or sedation use.
A full-text review was performed of any remaining stud-
ies following the title and abstract review. Additional stud-
ies that did not meet inclusion criteria were excluded.
Data Collection
The outcomes of interest were hospital mortality, length of
mechanical ventilation, length of ICU stay, incidence of pneu-
monia, laryngotracheal injury, and sedation use. A detailed
data collection sheet was created based on the outcomes of
interest. This underwent multiple revisions by the reviewers
before data collection to ensure usability and consistency. Data
were collected independently by 3 reviewers (C.C.L., E.D.,
and J.D.). During the data collection process, the risk of bias
for each study was assessed. Various risk of bias scales exist,
and there is no one scale that is clearly validated.9-11 We
chose to use the criteria from the Cochrane Handbook for
Systematic Reviews of Interventions.12
Otolaryngology–Head and Neck Surgery 152(2)
Statistical Analysis
Relative risk (RR) with 95% confidence intervals (CIs) was
used to express differences for dichotomous variables.
Weighted mean differences (WMDs) with 95% CIs were
used for continuous variables. The I2 statistic was used to
quantify heterogeneity, whereby I2 of 0% to 40% might not
be important, 30% to 60% may indicate moderate heteroge-
neity, 50% to 90% may indicate substantial heterogeneity,
and 75% to 100% indicates considerable heterogeneity.12
We only performed pooled analysis when the heterogeneity
was less than 60%. Data analysis was performed using a
random-effects model, given the varied patient populations
and study methodologies. A P value of \.05 was considered
significant. Where meta-analysis was performed, sensitivity
analysis was undertaken by removing individual studies
from the pooled results to assess the extent to which each
study contributed to the effect size and heterogeneity.
RevMan 5 software (Cochrane Collaboration, Oxford,
England) was used for all statistical analyses.
Subgroup analysis was performed to investigate whether
certain clinical or methodological characteristics of the
studies could account for the statistical heterogeneity seen
and whether these characteristics influenced the results of
the meta-analysis. Specifically, we performed subgroup
analysis based on the timing of the early tracheostomy (ie,
3 days, 4-5 days, 7-8 days), as studies differed in their
definitions of early and late tracheostomy. We also exam-
ined outcomes based on the etiology of acute illness of the
study population.
This study contains only data from the published literature,
and no patient data were used; therefore, institutional review
board and ethics committee approval was not required.
Results
A total of 3893 studies were identified following the initial
search. A title and abstract review excluded 3873 studies,
leaving 20 studies for full-text review. One additional study
was identified during the bibliography search of relevant
studies for a total of 21 studies. Following full-text review,
11 studies remained (Figure 1). Table 1 summarizes the
key features of the included studies, and Table 2 sum-
marizes the risk of bias assessment. The etiology of the crit-
ical illness of the study populations varied from medical,
neurological, traumatic, to mixed. The timing of the early
tracheostomy differed significantly across studies, ranging
from 2 to 8 days. The definition of late tracheostomy also
varied, ranging from 6 to 28 days. In 2 studies, late tra-
cheostomies were performed during a time frame that fell
into most other studies’ definitions of early tracheost-
omy.13,14 This overlapping of groups may cause inaccurate
results in a meta-analysis, as the effects attributed to
patients in the late groups in these studies may negate simi-
lar effects attributed to patients in the early groups in other
studies. As such, these studies were not included in the
pooled analyses. No life-threatening complications were
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
group and 24 days for the late tracheostomy group. A pooled
analysis was attempted, but once again, the heterogeneity was
found to be considerable (I2 = 99%); therefore, we present the
measured effects from the individual studies without a pooled
result (Figure 3). Rodriguez et al17 reported a significantly
decreased length of mechanical ventilation in the early tra-
cheostomy group, with a mean difference of 220 days (95%
CI, 220.8 to 219.2, P \ .05), as did Rumbak et al,18 with a
mean difference of 29.8 days (95% CI, 211.5 to 28.12,
Liu et al
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
decrease in the length of mechanical ventilation, with a mean
difference of 21.6 days (95% CI, 23.33 to 0.13, P = .06).
Finally, Saffle et al19 found an increase in the length of
mechanical ventilation, with those in the early tracheostomy
group requiring 4.10 more days than those in the late tra-
cheostomy group (95% CI, 1.23 to 6.97, no P value reported).
ICU Length of Stay
Four studies reported data on ICU length of stay (Figure
4).17,18,20,23 The pooled results favored early tracheostomy, with a
weighted mean difference of 29.13 days (95% CI, 217.55 to
20.70, I2 = 100%, P = .03). Sensitivity analysis showed that the
studies were equal in their contribution to the heterogeneity. The
study results were pooled despite the significant heterogeneity
because all of the measured effects were in the same direction,
favoring early tracheostomy; therefore, the true effect likely also
lies in this direction. A pooled analysis in this case likely captures
the true effect, despite significant statistical heterogeneity.
Hospital Mortality
To maximize the information captured and analyzed, we
defined mortality broadly in our protocol as hospital mortal-
ity. This definition included ICU, 28-day and 30-day mortal-
ity, and hospital mortality. Eight studies reported data on
mortality (Figure 5).15,17-23 The proportion of patients who
died in the early tracheostomy group was 30.7%, compared
with 34.7% in the late tracheostomy group. The weighted
absolute risk reduction was not significant. Similarly, there
223
was no significant reduction in the relative risk (RR, 0.84;
95% CI, 0.67 to 1.04; I2 = 34%, P = .11). When sensitivity
analysis was performed for this outcome, the Rumbak et al18
study was found to contribute to most of the heterogeneity;
however, removing this study from the analysis did not
change the significance of the findings.
Sedation Use and Laryngotracheal Injury
Sedation use and laryngotracheal injury were also outcomes
of interest in our meta-analysis, as both are of clinical sig-
nificance. Data regarding these outcomes, however, could
only be qualitatively summarized as they were heteroge-
neous and could not be combined in a quantitative analysis.
Bosel et al13 found a significant decrease in the use of
sedatives in the early tracheostomy group compared with
the late tracheostomy group, with each group requiring
sedatives during 42% and 62% of the ICU stay, respectively
(median difference, 17.5 days; 95% CI, 3.3-29.2; P = .02).
Furthermore, they found that patients in the early tracheost-
omy group scored lower on the Richmond Agitation
Sedation Scale and spent more time under assisted rather
than controlled ventilation. Rumbak et al18 also found a sig-
nificant decrease in sedation use, with a mean (SD) of 3.2
(0.4) days of sedation in the early tracheostomy group com-
pared with a mean (SD) of 14.1 (2.9) days of sedation in the
late tracheostomy group (P \ .001). Finally, Young et al23
found a significant decrease in the median number of days
of sedation use in the early tracheostomy group compared
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-
yngotracheal injury as an outcome.16,18,20 The results from
these studies are presented in Table 3. Sugerman et al20 per-
formed laryngoscopy in 83 of 112 patients, either at the time
of tracheostomy performance or upon extubation. In those who
received a tracheostomy, 41 underwent laryngoscopy at the time
of decannulation. They found a nonsignificant trend toward a
higher incidence of airway ulceration and inflammation in the
late tracheostomy group. Specifically, they found a 35.3% inci-
dence of vocal cord ulceration in the early tracheostomy group
compared with 67.6% in the late tracheostomy group, while
subglottic inflammation was found in 0% and 39.3% of the
early and late tracheostomy groups, respectively. The incidence
of ulceration and inflammation at other laryngotracheal sites is
shown in Table 3. Patients who were symptomatic or had an
initial injury of Lindholm class II or worse were reassessed at 3
to 5 months. No evidence of late complications was found in
either the early or late tracheostomy group. Rumbak et al18 per-
formed airway assessments via bronchoscopy at the time of tra-
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
group (68.3% vs 38.3%); however, this was not statistically sig-
nificant. Finally, Dunham and LaMonica16 assessed for laryngo-
tracheal injury using flexible laryngoscopy following extubation
or decannulation. However, unlike the other 2 studies, they
assessed only patients who were symptomatic of upper airway
obstruction. They found early laryngotracheal injury in 17.6%
and 12.5% of the early and late tracheostomy groups, respec-
tively. This difference was not significant. Outcomes regarding
late laryngotracheal injury were not reported.
Subgroup Analysis
Subgroup analysis was performed to examine whether the
pooled results were influenced by the precise timing of the
tracheostomy and the illness population.
The analyzed studies varied in their definitions of early
tracheostomy, ranging from 2 to 8 days after intubation.
Table 4 summarizes the incidence of pneumonia, length of
ventilation, length of ICU stay, and hospital mortality based
on the timing of the early tracheostomy. We did not find a
significant difference in any of the outcomes of interest
based on the timing of tracheostomy.
The studies encompassed a variety of patients, including
trauma, neurological, medical, and mixed medical, and sur-
gical. Therefore, subgroup analysis was performed with
regard to the etiology of critical illness to determine
whether specific populations of patients were more likely to
benefit from an early tracheostomy. A pooled analysis did
not find a significant difference in outcomes based on the
etiology of illness.
Discussion
Our meta-analysis suggests that when performed within 7
days, an early tracheostomy leads to a decreased length of
ICU stay compared with late tracheostomy. No difference was
seen in hospital mortality. A pooled analysis could not be per-
formed for the incidence of pneumonia and length of mechani-
cal ventilation secondary to significant heterogeneity. The
incidence of pneumonia as well as the length of mechanical
ventilation reported by the reviewed studies varied in direction,
with some reporting a benefit while others reported a detriment
Liu et al
Table 4. Outcomes Based on Timing of Early Tracheostomy.
Incidence of
Timing of Tracheostomy Pneumonia
3 days18,22 RR = 0.38
95% CI = 0.13 to 1.16
I2 = 67%
P = .09
4-5 days16,19,20,23 RR = 1.03
95% CI = 0.92 to 1.15
I2 = 0%
P = .58
7-8 days15,17,21 RR = 0.87
95% CI = 0.64 to 1.19
I2 = 87%
P = .37
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
sedation use did not lend themselves to a meta-analysis, all 3
studies examining this outcome found a significant decrease in
the early tracheostomy group.13,18,23
The risk of laryngotracheal injury is one of the chief con-
cerns for otolaryngologists when deciding to pursue to an
early tracheostomy. Our systematic review found that there
were no significant differences in the occurrence of early or
late injury based on the timing of tracheostomy.16,18,20
However, the included studies had small sample sizes. As
such, there is a high risk of type II error in these studies,
whereby they were likely inadequately powered to detect
any true differences that might have existed between the
treatment groups. Our finding of no difference may reflect
the inadequacy of the current evidence rather than a true
absence of benefit in performing an early tracheostomy.
Another concern in deciding to perform an early tracheost-
omy is whether it actually leads to higher rates of long-term
complications, such as tracheal stenosis, especially in
patients who may not have needed to undergo the procedure
because of successful later extubation. The results from
Rumbak et al18 suggested a possible increase in late tracheal
stenosis in the early tracheostomy group, albeit this differ-
ence was not significant. Therefore, at present, insufficient
evidence exists to substantiate or dispute this concern.
Studies with longer term follow-up are needed to assess the
true impact of an early tracheostomy on laryngotracheal out-
comes. This is an important issue that should be examined
in future investigations.
Our results differ from those of previous meta-analyses.
Griffith et al24 did not find a significant difference in mor-
tality or pneumonia, but they did find a significant decrease
in the duration of mechanical ventilation and ICU length of
stay. A subsequent meta-analysis by Wang et al25 did not
find a significant difference in any of the outcomes, includ-
ing mortality, pneumonia, length of mechanical ventilation,
225
Length of Mechanical Length of Hospital
Ventilation ICU Stay Mortality
— — RR = 0.77
95% CI = 0.29 to 2.03
I2 = 71%
P = .59
WMD = 1.13 WMD = 22.09 RR = 0.97
95% CI = 24.45 to 6.71 95% CI = 25.91 to 1.73 95% CI = 0.83 to 1.13
I2 = 91% I2 = 96% I2 = 0%
P = .69 P = .28 P = .70
— — RR = 0.81
95% CI = 0.61 to 1.06
I2 = 0%
P = .13
and length of ICU stay. The varying results may be attrib-
uted to certain methodological differences. Our protocol
excluded studies that compared early tracheostomy with
prolonged endotracheal intubation, whereas both Griffith
et al and Wang et al included these studies in their overall
analysis. This can be problematic because in the studies
investigating early tracheostomy versus prolonged intubation,
data regarding the number of patients requiring a late tra-
cheostomy, the day of late tracheostomy, and these patients’
outcomes are often not explicitly stated. Therefore, it may be
inappropriate to combine the outcomes from these studies with
those looking at early versus late tracheostomy, as they are
measuring different treatment effects. Our meta-analysis also
included 4 additional trials that have been reported since the
Wang et al study. Finally, we employed a more conservative
and rigorous approach in the statistical analysis and interpreta-
tion of our data. Specifically, we chose to forego pooled analy-
ses for 2 of our outcomes due to significant heterogeneity. In
both the Griffith et al and Wang et al studies, data were com-
bined for every outcome even when significant heterogeneity
was found (with the I2 statistic ranging from 58% to 87% in
the Griffith et al study and 0% to 98% in the Wang et al
study). The following paragraph discusses the issue of combin-
ing data in the presence of high statistical heterogeneity.
A common limitation encountered in meta-analyses,
including the present one, is the heterogeneity of the data.
Heterogeneity can result from both clinical variability of the
study populations as well as methodological variability from
the performance of the studies.12 In meta-analyses examin-
ing the issue of early versus late tracheostomy, the major
sources of heterogeneity are the varying inclusion and
exclusion criteria employed by each trial, the diverse patient
populations, tracheostomy techniques, and particularly the
varied definitions of early and late tracheostomy. These var-
iations may result in more than one intervention effect. In
this case, a pooled result would not be appropriate, as it
226
would not capture a real effect in any of the populations. In
our study, we decided to pool the data only if the heteroge-
neity was moderate or lower (I2  60%). The exception was
for ICU length of stay. We pooled the results for this out-
come as the measured effects from each study were in the
same direction, favoring early tracheostomy. In this case,
the true effect likely lies in that direction, and we felt that a
pooled analysis would best capture this.
A second limitation of our study is that we may not have
included all randomized and quasi-randomized trials com-
paring the outcomes of early tracheostomy with late tra-
cheostomy. We performed a thorough search and minimized
the chance of missing relevant studies by having an inclu-
sive search strategy performed systematically by two
reviewers. The literature search, however, was limited to
articles in the English language; therefore, publications in
other languages may have been missed.
Finally, an important limitation of studies examining the
optimal timing of tracheostomies is the accuracy with which
the length of mechanical ventilation can be predicted. Most
studies included in our meta-analysis enrolled patients who
were predicted to require prolonged mechanical ventilation
based on the clinical acumen of the investigators. Two stud-
ies used institution-specific and nonvalidated tools. Only
one study used a validated tool; however, this tool is spe-
cific to burn patients and therefore is not applicable to other
critical care populations.26 Four studies provided data
regarding the number of late tracheostomies actually per-
formed.18,19,21,22 In these studies, a total of 354 patients
were randomized to receive a late tracheostomy, and of
these patients, 62 (17.5%) did not receive a tracheostomy as
they were successfully weaned from mechanical ventila-
tion and extubated. Our inability to accurately predict the
need for mechanical ventilation is important to keep in
mind when considering early tracheostomies, as there are
a proportion of patients who may receive this intervention
unnecessarily. An important area for future research
would be the development of validated scoring systems,
allowing for more accurate prediction of prolonged
mechanical ventilation.
Conclusion
Our systematic review and meta-analysis found that when
performed within 7 days, an early tracheostomy was sig-
nificantly associated with a decreased length of ICU stay.
There was no difference in hospital mortality. There is
not enough evidence at present to support an early tra-
cheostomy with regard to the incidence of pneumonia or
length of mechanical ventilation. Subgroup analysis did
not suggest a difference in outcomes based on the etiol-
ogy of critical illness or whether the early tracheostomy
was performed at 2 to 3 days, 4 to 5 days, or 7 to 8 days
of endotracheal intubation.
Acknowledgments
We thank Dr Brar for his assistance in devising the data collection
sheet and Dr Kassam for her help in reviewing our method.
Otolaryngology–Head and Neck Surgery 152(2)
Author Contributions
C. Carrie Liu, conception of study, acquisition of data, data analy-
sis, draft, revision and final approval of manuscript; Devon
Livingstone, acquisition of data, revision and final approval of
manuscript; Elijah Dixon, acquisition of data, revision and final
approval of manuscript; Joseph C. Dort, conception of study,
acquisition of data, revision and final approval of manuscript.
Disclosures
Competing interests: None.
Sponsorships: None.
Funding source: None.
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