The Clinical Respiratory Journal REVIEW ARTICLE

Early vs late tracheostomy in critically ill patients: a systematic

review and meta-analysis
Liang Meng, Chunmei Wang, Jianxin Li and Jian Zhang
Intensive Care Unit of Vascular Surgery Department, Xuanwu Hospital, Capital Medical University, Beijing, China

Abstract Key words

Background and Aims: This study aims to compare the outcomes of early trache- intensive care unit – meta-analysis – mortality
– tracheostomy – ventilator-associated
ostomy (ET) (≤10 days after translaryngeal intubation) with late tracheostomy (LT)
pneumonia
(>10 days after translaryngeal intubation) in critically ill patients with prolonged
mechanical ventilation (MV). Correspondence
Methods: We searched PubMed, EMBASE and the Cochrane Library from incep- Chunmei Wang, MD, Intensive Care Unit of
tion to April 2014. We included all randomized controlled trials (RCTs), which Vascular Surgery Department, Xuanwu
compared ET with LT in critically ill patients. There was no language restriction. Hospital, Capital Medical University, 100053
Two authors extracted data and conducted a quality assessment. Meta-analyses Beijing, China.
Tel: +86 010 83198647
using the fixed-effects or random-effects model were conducted for mortality,
Fax: +86 010 83125113
incidence of ventilator-associated pneumonia (VAP), duration of MV and seda- email: drwangchunmei@sina.com
tion, length of intensive care unit (ICU) stay.
Results: We enrolled 9 studies, in which a total of 2040 patients were randomized Received: 19 June 2014
to either ET group (N = 1018) or LT group (N = 1022). ET might reduce the Accepted: 28 February 2015
duration of sedation [weighted mean difference (WMD) = −5.99 days; 95% confi-
dence intervals (CI) = −11.41 to −0.57 days; P = 0.03]. ET did not significantly alter DOI:10.1111/crj.12286
the mortality [relative risk (RR) = 0.88; 95% CI = 0.76–1.00; P = 0.06], incidence of
Authorship and contributorship
VAP (RR = 0.84; 95% CI = 0.66–1.08; P = 0.17), duration of MV (WMD = −4.46 Liang Meng and Chunmei Wang selected
days; 95% CI = −12.61 to 3.69 days; P = 0.28) and length of ICU stay studies and extracted and analyzed data.
(WMD = −7.57 days; 95% CI = −15.42 to 0.29 days; P = 0.06). Liang Meng wrote the paper. Chunmei Wang,
Conclusions: Our meta-analysis suggested that ET might be able to reduce the Jianxin Li and Jian Zhang revised the
duration of sedation but did not significantly alter the mortality, incidence of VAP, manuscript. All authors have read and
duration of MV and length of ICU stay. approved this version of the article.

Conflict of interest
Please cite this paper as: Meng
Meng L, Wang C, Li J and
L,Wang and Zhang
Zhang J.J. Early
Early vs
vs late
latetracheos-
tracheos- The authors have stated explicitly that there
tomy in critically
critically ill patients:
patients: aa systematic
systematic review
review and
and meta-analysis.
meta-analysis. ClinClin Respir
Respir JJ are no conflicts of interest in connection with
2015; 10:
2016; ••: ••–••. DOI:10.1111/crj.12286.
684–692. DOI:10.1111/crj.12286. this article.

patient comfort, ability to oral feeding and communi-

Introduction
Tracheostomy is a common procedure performed to
replace the translaryngeal intubation in the inten-
sive care unit (ICU), when the patients need pro-
longed intubation (PI) with mechanical ventilation
(MV) and fail to wean from the ventilation in the near
future.
Compared with the prolonged translaryngeal intu-
bation, tracheostomy may offer several advantages
such as avoiding injury to the larynx, improving
cation and facilitating nursing care (1–3). Several
studies indicated that tracheostomy might decrease the
incidence of ventilator-associated pneumonia (VAP),
the duration of MV and the length of ICU stay (4–6).
Tracheostomy is an invasive procedure, there are
several complications such as bleeding, stomal infec-
tion, pneumothorax and tracheal stenosis (7, 8). There
are two major techniques for tracheostomy, including
open surgical tracheostomy (ST) and percutaneous
dilatational tracheostomy (PDT). PDT expands the

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Table 1. Search terms and strategy on PubMed
#1 (((tracheostomy) OR tracheotomy) OR tracheostomies)
OR tracheotomies
#2 ((early) OR late) OR timing
#3 (((((Mechanical) OR Ventilation) OR Ventilator) OR
artificial)) OR airway
#4 Humans[Mesh]
#5 #1 AND #2 AND #3 AND #4
application of tracheostomy because it can be per-
formed by intensive care physicians at the bedside.
A consensus conference recommended trans-
laryngeal intubation for patients need of the artificial
airway up to 10 days and performing tracheostomy
after 21 days of intubation (9). But the timing of tra-
cheostomy is still debated.
Four meta-analyses have been published in English
regarding the relationship between the timing of tra-
cheostomy and the prognosis of patients (10–13). All
of these meta-analyses compared early tracheostomy
(ET) with late tracheostomy (LT) or PI to assess the
influence of timing of tracheostomy on the mortality,
the duration of MV and ICU stay and other clinical
outcomes. Gomes Silva Brenda et al. (14) in 2012
excluded studies compared ET with PI and only
reviewed studies compared ET with LT. But they only
enrolled three randomized controlled trials (RCTs)
and could not pool data in a meta-analysis because of
clinical, methodological and statistical heterogeneity
between the included studies. After Gomes Silva Bren-
da’s meta-analysis, several new RCTs have been pub-
lished concerning the comparison of the prognosis of
critically ill patients who underwent ET with LT (1, 5,
15, 16). We undertook a systematic review and meta-
analysis of RCTs to investigate the effects of ET vs LT
on clinical outcomes in critically ill patients.
Materials and methods
Search strategy
To find relevant studies for this meta-analysis, a search
of PubMed (Table 1), EMBASE and the Cochrane
Library was carried out by two authors independently
from inception to April 2014. No limits for language,
gender, sample size and place of study origin were
entered for the search. Boolean operators (AND, OR,
NOT) were used to narrow and widen the search
results. The titles and the abstracts from the search
results were examined closely and were determined to
be suitable for potential inclusion into the study. In
addition, the references from selected articles and pre-
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Meng et al.
vious meta-analyses were examined as a further search
tool to find additional studies.
Inclusion and exclusion criteria
Studies were eligible for the analysis if they met all of
the following inclusion criteria: (i) RCTs; (ii) there was
no limit to the procedure of tracheostomy; (iii)
patients were assigned to the ET group or the LT group
(we defined ET as a tracheostomy that was performed
within 10 days after translaryngeal intubation; con-
versely, LT was performed more than 10 days after
translaryngeal intubation); (iv) studies should contain
one of the following outcomes at least: mortality, dura-
tion of MV, duration of sedation, length of ICU stay
and incidence of VAP.
Studies were excluded if they met one of the follow-
ing exclusion reasons: (i) the studies were quasi-RCTs;
(ii) ET was performed more than 10 days after
translaryngeal intubation or LT was performed within
10 days after translaryngeal intubation; (iii) the data
were incomplete.
Two authors screened the search results following
inclusion and exclusion criteria independently.
Data extraction, quality and
risk-of-bias assessment
For quality assessment and statistical analysis, two
authors independently extracted the following data:
first author, publication year, number of patients,
approach of tracheostomy (PDT or ST), clinical
outcome data, definition of VAP and Jadad score (17)
of methodological quality of the study. The primary
outcome was mortality. The secondary outcomes were
incidence of VAP, duration of MV and sedation, and
length of ICU. Mortality was defined as hospital mor-
tality or mortality in 30 days.
We used the Jadad 5-point scale to evaluate the
methodological quality of the included studies. The
studies were regarded to be of high quality if the Jadad
score was equal or higher than 3 points and low quality
if the score was equal or lower than 2 points.
Additionally, we also assess the risk-of-bias studies
with the method recommended by a Cochrane Col-
laboration tool.
Statistical analysis
Differences were expressed as relative risks (RRs) with
95% confidence intervals (CIs) for dichotomous out-
comes, and weighted mean differences (WMDs) with
95% CIs for continuous outcomes. Heterogeneity was
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tested by using the I2 statistic. A random-effects model
was used in the case with significant heterogeneity
(I2 ≥ 50%). A fixed-effects model was used in the case
without significant heterogeneity (I2 < 50%). Potential
sources of heterogeneity were identified by sensitivity
analyses conducted by deleting one study in each turn
or deleting the low-quality studies and investigating
the influence of a single study on the overall pooled
estimate. Publication bias was assessed by a funnel plot.
A P value < 0.05 was considered statistically signifi-
cant. All statistical analyses were performed using
Review Manager 5.2 (RevMan 5.2; The Cochrane Col-
laboration, Oxford, UK).
Results
Study selection
The search yielded a total of 1516 relevant publica-
tions, and the abstracts were obtained for all citations.
We excluded 209 publications because of duplication.
We excluded 1290 studies based on the titles and
abstracts because 1189 studies of them did not concern
the timing of tracheostomy and 101 studies of them
were not RCTs. Then, the full texts of 17 studies were
read for further evaluation, and 8 studies were
excluded because one study was quasi-RCT (18), 4
studies compared ET with PI (4, 19–21) and 3 studies
performed LT within 10 days after translaryngeal intu-
bation (22–24). The flow chart of our selection process
is shown in Fig. 1.
Figure 1. Flow diagram showing the selection process for
included studies. RCTs, randomized controlled trials.
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Figure 2. Risk-of-bias graph: review authors’ judgments about
each risk-of-bias item presented as percentages across all
included studies. , Low risk of bias; , unclear risk of bias; ,
high risk of bias.
Characteristics, quality and bias assessment of
included studies
Table 2 shows the main characteristics of the nine
studies, published up to April 2014, included in
this analysis. All of these studies were published
in English. These studies enrolled a total of 2040
patients, 1018 of them were allocated to ET group
and 1022 of them were allocated to LT group. These
studies enrolled various clinical conditions, including
nonselective critical illness, postsurgery, trauma and
burn injury. All of nine studies reported the outcome
of mortality (Table 3).
The range of Jadad scores of the studies is from 2
to 5 (Table 4). Figs. 2 and 3 show the overall meth-
odological quality of the RCTs included by the
Cochrane Collaboration tool for assessing risk of bias.
One study (5) did not describe the methods of
randomization and allocation concealment. Only two
studies (1, 25) described the methods of blinding.
The risk of reporting bias was small because the out-
comes of interest in all of the studies were described
adequately.
Primary outcome: mortality
All of the nine studies reported the mortality. A total of
273 of 1018 patients died in the ET group, and 312 of
1021 patients died in the LT group. There was no sig-
nificant heterogeneity in this outcome (P for heteroge-
neity = 0.24; I2 = 23%) (Fig. 4). The pooled analysis
using the fixed-effects model showed that there was
no significant statistical difference in the mortality
between the ET group and the LT group (RR = 0.88;
95% CI = 0.76–1.00; P = 0.06).
Secondary outcomes: incidence of VAP, duration
of MV and sedation and length of ICU stay
Eight studies (1, 5, 6, 15, 25–28) evaluated the inci-
dence of VAP. We used a random-effects model, which
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 Table 2. Summary characteristics of the included studies

V
The
Surgical
Meng

Study/year published ICU setting approach ET group LT group Outcomes VAP definition
Mohamed et al. 2014 (5) ICU PDT Within 10 days After 10 days Not reported
et al.

①②③⑤
Young et al. 2013 (16) 70 adult general and 2 PDT/ST Within 4 days After 10 days ① Not reported
Tracheostomy,

cardiothoracic CCUs
Zheng et al. 2012 (1) Surgical ICU PDT Day 3 of MV Day 15 of MV ①②④ Using the modified CPIS.
Trouillet et al. 2011 (15) Postcardiac surgery ICU PDT Before 5 days after surgery 15 days after MV ①②③④⑤ Clinical features with positive

C 2015 John Wiley & Sons Ltd

BAL cultures
meta-analysis

Terragni et al. 2010 (25) 12 ICUs PDT After 6–8 days of intubation After 13–15 days of ①② Using the modified CPIS.
intubation
Blot et al. 2008 (27) 25 Medical or surgical ICUs PDT/ST Within 4 days After 14 days of intubation ①② Clinical features with positive
BAL cultures
Barquist et al. 2006 (28) Trauma center ICU ST Before day 8 After day 28 ①②⑤ CDC criteria
Rumbak et al. 2004 (6) 3 Medical ICUs PDT Within 48 h Days 14–16 of MV ①②③④⑤ Clinical features with positive

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BAL cultures
Saffle et al. 2002 (26) Burn ICU ST 4 days after burn Injury 14 days after burn injury ①②③ CDC criteria

BAL, bronchoalveolar lavage; ICU, intensive care unit; MV, mechanical ventilation; VAP, ventilator-associated pneumonia; CPIS, Clinical Pulmonary Infection Score; CDC, Centers for Disease Control
and Prevention; ET, early tracheotomy; LT, late tracheotomy; PI, prolonged intubation; PDT, percutaneous dilatational tracheostomy; ST, surgery technique; BAL, bronchoalveolar lavage.
① mortality; ② incidence of VAP; ③ duration of MV; ④ duration of sedation; ⑤ length of ICU stay.

Table 3. Summary of outcomes of included studies

Patients Mortality Incidence of VAP Duration of MV Duration of sedation Length of ICU stay
No. No.(%) No.(%) Mean ± SD Mean ± SD Mean ± SD
Study/Year
published ET LT ET LT ET LT ET LT ET LT ET LT
Mohamed et al. 20 20 8 (40%) 8 (40%) 4 (20%) 8 (40%) 20.6 ± 13.03 32.2 ± 10.52 – – 21.05 ± 13.46 40.15 ± 12.72
2014 (5)
Young et al. 451 448 139 (30.2%) 141 (31.5%) – – – – – – – –
2013 (16)
Zheng et al. 58 61 8 (13.8%) 6 (9.8%) 17 (29.3%) 30 (49.2%) – – 7.16 ± 2.35 10.95 ± 2.3 – –
2012 (1)
Trouillet et al. 109 107 17 (15.6%) 23 (21.5%) 50 (45.9%) 47 (43.9%) 17.9 ± 14.9 19.3 ± 16.9 6.4 ± 5.9 9.6 ± 7.3 23.9 ± 21.3 25.5 ± 22.2
2011 (15)
Terragni et al. 209 210 55 (26.3%) 66 (31.4%) 30 (14.4%) 44 (21.0%) – – – – – –
2010 (25)
Blot et al. 2008 61 62 21 (34.4%) 20 (32.3) 30 (49.2%) 31 (50%) – – – – – –
(27)
Barquist et al. 29 31 2 (6.9%) 5 (16.1%) 28 (96.6%) 28 (90.3%) – – – – 25.04 ± 6 24.74 ± 6.5
2006 (28)
Rumbak et al. 60 60 19 (31.7%) 37 (61.7%) 3 (5%) 15 (25%) 7.6 ± 4 17.4 ± 5.3 3.2 ± 0.4 14.1 ± 2.9 4.8 ± 1.4 16.2 ± 3.8
2004 (6)
Saffle et al. 21 23 4 (23.5%) 6 (35.3%) 21 (100%) 22 (95.7%) 35.5 ± 4.5 31.4 ± 5.2 – – – –
Tracheostomy, meta-analysis

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2002 (26)

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ET, early tracheotomy; ICU, intensive care unit; LT, late tracheotomy; MV, mechanical ventilation SD, standard deviation; VAP, ventilator-associated pneumonia.
Tracheostomy,
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Table 4. Jadad scores of included studies
Study/Year published
Mohamed et al. 2014 (5)
Young et al. 2013 (16)
Zheng et al. 2012 (1)
Trouillet et al. 2011 (15)
Terragni et al. 2010 (25)
Blot et al. 2008 (27)
Barquist et al. 2006 (28)
Rumbak et al. 2004 (6)
Saffle et al. 2002 (26)
Figure 3. Risk-of-bias summary: review authors’ judgments
about each risk-of-bias item for each included study.
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Randomization Double blinding Withdrawals and dropouts Total score
1 0 1 2
2 0 1 3
2 2 1 5
2 0 1 3
2 2 1 5
2 0 1 3
2 0 1 3
1 0 1 2
2 0 1 3
shows that the incidence of VAP in the ET group was
not significantly different from the LT group
(RR = 0.84; 95% CI = 0.66–1.08; P = 0.17), with statis-
tical evidence of heterogeneity among the studies
(I2 = 82%) (Fig. 5).
Three studies (1, 25, 28) reported the mean [stand-
ard deviation (SD)] time duration of MV free. Four
studies (5, 6, 15, 26) reported the mean (SD) time
duration of MV. The pooled analysis of four studies (5,
6, 15, 26) showed no significant difference between the
ET group and the LT group (WMD = −4.46 days; 95%
CI = −12.61 to 3.69 days; P = 0.28). Significant hetero-
geneity in this outcome was observed among the
included studies (I2 = 96%) (Fig. 6).
Three studies (1, 6, 15) reported the mean (SD) time
duration of sedation. The pooled analysis indicated
that ET could reduce the duration of sedation
(WMD = −5.99 days; 95% CI = −11.41 to −0.57 days;
P = 0.03). Significant heterogeneity in this outcome
was observed among the included studies (I2 = 99%)
(Fig. 7).
Four studies (5, 6, 15, 28) reported the mean (SD)
time length of ICU stay and showed that there was not
significant reduction of ICU stay in the ET group
(WMD = −7.57 days; 95% CI = −15.42 to 0.29 days;
P = 0.06). Significant heterogeneity in this outcome
was observed among the included studies (I2 = 95%)
(Fig. 8).
Sensitivity analyses
We performed sensitivity analyses to explore the
potential sources of heterogeneity. Exclusion of the
study by Rumbak et al. (6) resolved the heterogeneity
in duration of sedation (P for heterogeneity = 0.56;
I2 = 0%). Exclusion of the study by Rumbak et al. (6)
and Mohamed et al. (5) resolved the heterogeneity in
the length of ICU (P for heterogeneity = 0.57; I2 = 0%).
We found that result of duration of sedation and the
length of ICU stay had not been significantly changed.
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Figure 4. Forest plot shows the comparison of the mortality between the ET group and the LT group. CI, confidence interval; df,
degrees of freedom; ET, early tracheotomy; LT, late tracheotomy; M-H, Mantel–Haenszel.

Using mortality as an endpoint, the funnel plot did not
suggest the significant presence of publication bias
(Fig. 9).
Discussion
There have been four meta-analyses published in
English to elaborate the relationship between the
timing of tracheostomy and the prognosis of patients
(10–13). All of these meta-analyses compared ET with
LT or PI to assess the influence of timing of tracheos-
tomy on the mortality, the duration of MV and ICU
stay and other clinical outcomes. The meta-analysis,
published by Griffiths et al. (11), showed that ET could
reduce the duration of MV and the length of ICU stay.
But two studies enrolled in Griffiths’ meta-analysis
were quasi-RCTs and might produce selection bias.
The later three meta-analyses (10, 12, 13) enrolled
RCTs showed no significant difference in the mortality,
duration of MV, length of ICU and incidence of VAP.
We excluded the studies that compared ET with PI and
included the newest study published by Mohamed
et al. to further compare the ET with LT.
With advances and improvements in critical care
medicine, more patients survived the initial episodes of
critical illness, such as acute respiratory failure, trauma
and extensive surgeries, and required prolonged MV.
So, there were more patient in need of tracheostomy to
replace the translaryngeal intubation in the ICU. There
was no consistency about timing of the tracheotomy.

Figure 5. Forest plot shows the comparison of incidence of ventilator-associated pneumonia between the ET group and the LT
group. CI, confidence interval; df, degrees of freedom; ET, early tracheotomy; LT, late tracheotomy; M-H, Mantel–Haenszel.

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Figure 6. Forest plot shows the comparison of duration of mechanical ventilation between the ET group and the LT group. CI,
confidence interval; df, degrees of freedom; ET, early tracheotomy; LT, late tracheotomy; M-H, Mantel–Haenszel.

In a nationwide survey in 455 German ICUs, Kluge
et al. (29) found that 68.2% of tracheostomies were
performed during the second week of MV and 21.7%
of tracheostomies were performed during the first
week. An international utilization review in 412
medical-surgical ICUs, Esteban et al. (30) reported that
tracheostomies were performed at a median period of
11 days after intubation. Thus, we defined ET as tra-
cheotomy performed within 10 days after intubation in
our meta-analysis.
We investigated the influence of important clinical
outcomes in critically ill patients who received ET or
LT during their treatment. Meta-analysis showed that
ET did not significantly reduce mortality, incidence of
VAP, duration of MV and length of ICU stay. Signifi-
cant heterogeneity was observed among these studies,
except the pooled analysis of mortality. The heteroge-
neity could be caused by differences in several aspects.
The inclusion and exclusion criteria differed across
the studies. Only one study (26) described the method
to predict which patient would require prolonged
ventilation, and such formula applicable to the general
population had yet to be produced and validated. A
sensitive and validated formula to identify early those
who need prolonged MV is warranted in the future. In
the study of Rumbak et al. (6), the patients were moved
out of intensive care once the airway was secured and
the patients were hemodynamically stable. This study

Figure 7. Forest plot shows the comparison of duration of sedation between the ET group and the LT group. CI, confidence interval;
df, degrees of freedom; ET, early tracheotomy; LT, late tracheotomy; M-H, Mantel–Haenszel.

Figure 8. Forest plot shows the comparison of length of ICU stay between the ET group and the LT group. CI, confidence interval;
df, degrees of freedom; ET, early tracheotomy; LT, late tracheotomy; M-H, Mantel–Haenszel.

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attributed to the heterogeneity in the analysis of mor-
tality and length of ICU stay. The definition of pneu-
monia was different across the included studies. Two
studies adopted the Centers for Disease Control and
Prevention criteria, three studies defined pneumonia
based on clinical features with positive cultures of pul-
monary secretion samples and other two studies used
the simplified Clinical Pulmonary Infection Score
(CPIS) to diagnose pneumonia if CPIS was larger than
6 (Table 2). The difference of definition might attrib-
ute to the heterogeneity in the analysis of incidence of
VAP. A unified diagnosis of pneumonia should be
designed in future RCTs. Our meta-analysis indicated
that ET could reduce the duration of sedation. This
result might be related to the advantages of tracheos-
tomy such as improved patient comfort. But there were
only three studies (1, 6, 15) that reported the duration
of sedation, and the detailed protocol of use of seda-
tives was not reported. These might be attributed to the
heterogeneity. RCTs that enroll large samples powered
to address the duration of sedation related to ET were
warranted in the future.
The strength of our meta-analysis was that we had
defined rigorous inclusion and exclusion criteria and
had most pooled studies that enrolled large samples of
patients in a randomized controlled design. Neverthe-
less, several limitations of our meta-analysis should be
considered. It was possible that we did not retrieve all
available published research, but by performing a com-
prehensive and repeated search, we minimized this
risk. All of the studies included in our study were pub-
lished in English; there were three studies (5, 26, 28)
that included a small number of patients; the Jadad
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Figure 9. Funnel plot shows publication
bias for RR of the mortality.
scores of two studies (5, 6) were 2, and there was con-
siderable heterogeneity in our outcomes described
above.
Conclusion
In summary, our meta-analysis suggested that trache-
ostomy, performed within 10 days after translaryngeal
intubation in critically ill patients, might be able to
reduce the duration of sedation. But compared with
LT, ET did not reduce mortality, incidence of VAP,
duration of MV and length of ICU stay.
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