Journal of Evidence-Based Medicine ISSN 1756-5391

REVIEW

Cuff-leak test for predicting postextubation airway

complications: a systematic review
Ting Zhou1 , Hong-Ping Zhang1 , Wei-Wei Chen1 , Ze-Yu Xiong2 , Tao Fan3 , Juan-Juan Fu4 ,
Lei Wang1 and Gang Wang1
1
Pneumology Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University,
Chengdu, P.R. China
2
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh,
PA, USA
3
Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
4
Department of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, Newcastle University, NSW,
Australia

Keywords
cuff-leak test; postextubation airway
complications; accuracy; GRADE; systematic
review
Correspondence
Dr. G. Wang, MD & PhD, Pneumology
Group, Department of Integrated Traditional
Chinese and Western Medicine, West China
Hospital, Sichuan University, Chengdu
610041, P.R. China
Tel: 0086-8542-3546
E-mail: wcums-respiration@hotmail.com
Received 29 August 2011; accepted for
publication 17 October 2011.
doi: 10.1111/j.1756-5391.2011.01160.x
Abstract
Background and objective: Postextubation problems such as laryngeal edema and
reintubation are common complications after tracheal intubation. The cuff-leak test
has been proposed as a method of identifying those patients at high risk in clinical
practice, but its efficacy remains controversial.
Methods: We searched electronic databases including PubMed, the Cochrane Con-
trolled Trials Register, Web of Science, Ovid, and Embase. Studies were included
if they were concerned with accuracy of the cuff-leak test and the effect of cuff-
leak test screening on patient-important outcomes. Two reviewers independently
assessed study quality with the QUADAS tool and extracted data. We compiled
diagnostic two by two tables and pooled estimates of sensitivity and specificity, but
refrained from pooling when there was considerable clinical or statistical hetero-
geneity.
Results: Sixteen diagnostic tests with 3172 participants and six clinical trials with
2500 patients were identified. The median diagnostic odds ratios for predicting
postextubation laryngeal edema and reintubation were 18.16 (range, 3.54 to 356.00)
and 10.80 (2.74 to 1665.00), respectively. The accuracy of the cuff-leak test varied
with different methods, duration of intubation, and study population. An indirect
comparison found significant differences in post-extubation incidence of laryngeal
edema (OR = 2.09, 95% CI, 1.28 to 2.89) but not reintubation (OR = 0.94, 95%
CI, 0.32 to 1.57) if using cuff-leak test screening.
Conclusions: Our results suggest the cuff-leak test accurately predicts which adult
patients are at high risk of postextubation airway complications, but randomized
controlled trials are needed to further assess this diagnostic strategy.

Introduction
Translaryngeal intubation is a potentially life-saving proce-
dure for patients in respiratory distress, but it sometimes
generates local complications (1). Our recent study showed
that prophylactic administration of steroids in multidose
regimens before planned extubation reduces the incidence
of laryngeal edema after extubation and consequent rein-
tubation for adults (2), but Young et al. suggest that cor-
ticosteroids should be given only to patients at high risk
(3). However, pretreating patients with corticosteroids as-
sumes postextubation airway complications are predictable
events (4).
As the presence of an endotracheal tube precludes direct
visualization of the upper airway prior to extubation, a cuff-
leak test, which shows whether there is a leak around the

242 JEBM 4 (2011) 242–254 

c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
T. Zhou et al.
endotracheal tube with the cuff deflated, was first proposed
in 1988 as a simple method of predicting the occurrence of
postextubation airway complications (5). This test consists of
deflating the balloon cuff of the endotracheal tube in order to
assess the air leak around the tube, which permits an indirect
evaluation of upper airway patency (6).
A considerable number of studies on the cuff-leak test have
been published, but their results remain controversial (7–9),
leaving physicians to make difficult decisions regarding ex-
tubation. The GRADE (Grades of Recommendation, As-
sessment, Development, and Evaluation) approach provides
guidance on grading the quality of underlying evidence and
the strength of recommendations in health care. According
to the GRADE system, the best way to assess any diagnostic
strategy is a randomized controlled trial in which investi-
gators randomize patients to experimental or control diag-
nostic approaches and measure mortality, morbidity, symp-
toms, and quality of life (10). Although a meta-analysis on
the cuff-leak test’s accuracy was undertaken recently (11),
the test accuracy is at best a surrogate for patient-important
outcomes. Furthermore, that study lacked subgroup or com-
parative analyses, and did not link evidence on diagnosis
test accuracy to clinical practice. We performed the present
systematic review to establish the overall accuracy of the
cuff-leak test for predicting postextubation airway compli-
cations, which should trigger a clinical decision to initiate
treatment.
Methods
Ethical review
This study was designed as a systematic review, so it did not
require ethical approval, but we extracted any ethical review
information from included studies.
Search strategy and selection criteria
We searched electronic databases including PubMed (1980
to Jan 2011), CENTRAL (Cochrane Controlled Trials Regis-
ter, issue 1, 2011), Web of Science (1994 to Jan 2011), Ovid
(1994 to Jan 2011), and Embase (1984 to Jan 2011). Using
“cuff leak test”(13) as our only search term, we searched for
all clinical trials on the cuff-leak test, and scanned the refer-
ence lists of review articles and included studies to identify
other potentially eligible studies. There was no limitation on
language, year of publication, or publication status. Trials
were included if they involved diagnostic tests in adults and
had adequately reported data for calculating sensitivity and
specificity. After excluding duplicates, two reviewers (T.Z.
and W.W.C.) reviewed the full text of all pieces with titles
and abstracts that seemed to fit the criteria for inclusion.
JEBM 4 (2011) 242–254 
c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
Cuff-leak test and extubation
Data extraction
From each included article we extracted details on authors,
year of publication, study population, gender of subjects,
sample size, duration of intubation, test methods, diagnostic
cutoff points, true and false positive (TP and FP) and false
and true negative (FN and TN) subjects, and methodological
quality.
The two reviewers independently assessed the quality of
each study and extracted data. Disagreements were resolved
by consensus or by consulting a third reviewer (G.W.). If in-
formation was not reported adequately, we requested details
from the authors. If the authors did not respond to our letters,
the “unknown” items were treated as “no.” Each reviewer
extracted the data to construct a 2 × 2 table for every cutoff
point that was published in each study.
Reference standards and patient-important
outcomes
After extubation, stridor or dyspnea, an audible high pitched
inspiratory wheeze caused by turbulent airflow through nar-
rowed airways, is generally accepted as a clinical indication
of laryngeal edema (2). Major laryngeal edema necessitates
postextubation reintubation. Therefore, reference standards
for postextubation airway complications included laryngeal
edema and reintubation secondary to upper airway obstruc-
tion. In this study, our primary patient-important outcome
was laryngeal edema after extubation, with subsequent rein-
tubation necessitated by laryngeal edema as the secondary
patient-important outcome.
Quality assessment
We assessed the methodological quality of studies using
guidelines in the quality assessment for studies of diagnostic
accuracy (QUADAS) tool (maximum score, 14) (14). Qual-
ity scoring in QUADAS was undertaken, in which a score
of 1 was given when a criterion was fulfilled, 0 if a crite-
rion was unclear, and −1 if the criterion was not achieved.
Test accuracy studies with design deficiencies can produce
biased results (15). Accordingly, the following characteris-
tics in study design, which encompass some of the more
important forms of bias, were evaluated (13, 16): (1) cross-
sectional design; (2) sample size calculation; (3) consecutive
or random sampling subjects; (4) blinding; (5) prospective
data collection.
Effect of cuff-leak test screening
on patient-important outcomes
According to the GRADE system and using methods de-
tailed in a previous review (2), we evaluated whether there
243
Cuff-leak test and extubation T. Zhou et al.

was an effect of cuff-leak test screening—followed, when

Citations screened for titles and abstracts (n=118)
indicated, by prophylactic administration of steroids—on in-
cidence of postextubation airway complications such as la-
ryngeal edema and reintubation secondary to upper airway Duplicates excluded (n=38)
obstruction.

Unique abstracts identified (n=80)

Statistical analysis
For each study, the sensitivity, specificity, positive and nega- Irrelevant trials excluded
(n=42)
tive likelihood ratios (PLR and NLR), and diagnostic odds ra-
tio (DOR) were calculated. The DerSimonian Laird method
(random effects model) was used to incorporate variation Detailed information evaluated (n=38)
among studies when pooling sensitivity, specificity, PLR,
NLR, and DOR. Furthermore, a summary receiver operator
Not diagnostic tests (n=17)
characteristic (sROC) curve of all the studies was created, as
Letters (n=1)
this is a better summary of the study results than is a sin-
Comments (n=5)
gle jointed summary estimate of sensitivity and specificity.
Reviews (n=6)
The area under the sROC curve (AUC) was used to judge
Others (n=5)
the degree of accuracy of the tests according to published
guidelines (excellent: ≥0.97; very good: 0.93–0.96; good:
0.75–0.92; poor: 0.50–0.75) (17). Diagnostic tests included (n=21)
I2 or Q tests, though commonly used in meta-analysis,
are not recommended for assessing statistical homogeneity
Studies on children or infants
in diagnostic reviews because they do not take into account
(n=3)
the association between sensitivity and specificity. Statistical
heterogeneity was defined as an overlapping 95% confidence
interval (CI) of both sensitivity and specificity and differ- Potentially relevant trials (n=18)
ences in point estimates among the studies of less than 20%
(18, 19). In cases of statistical or clinical heterogeneity (in
In adequately reported
terms of characteristics of populations and test characteris-
information (n=2)
tics), we refrained from pooling and presented median values
Incomplete data (n=1)
and ranges instead. We carried out subgroup and compara-
Abstract only (n=1)
tive analyses to assess the effects of different methods of the
cuff-leak test, as well as the effects of risk factors for postex-
tubation airway complications (e.g., duration of intubation,
Eligible trials identified (n=16)
gender, and reason for admission) (20) on the accuracy of
the cuff-leak test, when each subgroup included data of at
Figure 1 Flow chart of study identification, inclusion, and exclusion
least four diagnostic studies. Furthermore, to assess the ef-
fects of QUADAS scores and other covariates (i.e., important
study design characteristics) on the diagnostic ability of the
cuff-leak test, we included them as covariates in univariate Results
meta-regression analysis.
Studies included
Investigating publication bias for diagnostic tests is prob-
lematic (21). Funnel plot-based tests used to detect pub- Our search strategy initially yielded 118 citations (Figure 1).
lication bias in reviews of randomized controlled trials Of these, 16 unique studies on predicting postextubation
have proven misleading for diagnostic studies (22). There- airway complications were included in our review; the in-
fore, we did not assess publication bias in this systematic cluded studies involved a total of 3172 participants (3218
review. extubations) (1, 7, 8, 23–35). In addition, six clinical tri-
The threshold of significance was set at P < 0.05. All als (2500 total patients) on prophylactic administration of
statistical analyses were performed using Stata version 8.0 steroids (with or without cuff-leak test screening) for pre-
(Stata Corp LP, College Station, Texas) and MetaDiSc ver- venting postextubation airway complications were identified
sion 1.1.1 (Zamora J, Muriel A, Abraira V, Madrid, Spain). (20, 24, 25, 36–38), as described in our previous review (2).

244 JEBM 4 (2011) 242–254 

c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
 Table 1 Characteristics of included studies

Extubations Suction of Intubated Ventilation Tidal Time

Study Study population n (% female) No. Age (y) Duration of intubation secretions route mode volume constraint (h)
T. Zhou et al.

Fisher 1992 Trauma or surgical 62 (NA) 62 NA 23.9 h NA NA NA NA NA

(35) patients
Marik 1996 Respiratory failure 100 (39.0) 100 57 ± 9 3.8 ± 3.2 d Unclear Oral and nasal AC NA 24

JEBM 4 (2011) 242–254 

(34) and postoperative
Miller 1996 Mechanically 88 (NA) 100 63 ± 17 5.8 ± 0.5 d Unclear Oral and nasal AC NA 24
(33) ventilated adult
patients
Engoren 1999 Cardiac surgery 524 (33.0) 531 65 ± 10 12.9 (10.5 to 21.2) h Y NA AC 10–12 mL/Kg NA
(32) population
Sandhu 2000 Trauma patients 110 (27.3) 110 NA 2.6 ± 2.6 d (n = 97); Y NA AC NA 24
(31)
5.9 ± 5.0 d (n = 7);
6.5 ± 1.9 d (n = 6)
De Bast 2002 General adult 76 (NA) 76 67 (51–76) Low leak: 3 (1 to 5) d; Unclear NA AC NA 24
(30) population high leak: 1 (1 to 5) d
Jaber 2003 ICU patients 112 (30.4) 112 Absence of stridor: Absence of stridor: 5.5 Y NA AC 10–12 mL/Kg NA
(29) 59 ± 16; Presence ± 6.3 d; Presence of
of stridor: 61 ± 19 stridor: 10.9 ± 7.0 d
Maury 2004 ICU patients 99 (47.5) 115 60 ± 19 3.5 ± 3.4 d Y Oral and nasal NA NA 24
(28)
Erginel 2005 Patients suffering 56 (NA) 67 63.6 ± 12.1 5.6 ± 4.6 d (>24 h) Y NA AC 7 mL/Kg NA
(27) from a variety of
respiratory disease
Kriner 2005 Medical and surgical 462 (46.8) 462 61 ± 17 5 ± 4 d (>24 h) Y Oral and nasal AC NA 24
(26) patients
Chung 2006 Acute respiratory 95 (33.7) 95 71.3 ± 13.6 28.1 ± 17.6 d Y NA AC 10 mL/Kg NA
(1) failure due to
various medical
causes
Cheng 2006 Medical and surgical 321 (NA) 321 >18 >24 h NA NA AC 8 mL/Kg 48
(25) patients
Lee 2007 (24) Medical care 365 (NA) 365 >18 >48 h Unclear NA VC 10 mL/Kg 48
population
Wang 2007 ICU patients 110 (52.7) 110 71 ± 13 13 ± 14 (1 to 65) d Y oral AC 10 mL/Kg NA
(8)

c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
Shin 2008 (7) Trauma patients 49 (32.7) 49 Cuff-leak present: Cuff-leak present: 87.1 NA NA AC 10 mL/Kg NA
36.5; absent: 38.1 h; absent: 36.6 h
Sukhupanvarak ICU patients 543 (41.1) 543 Presence of stridor: Presence of stridor: 5.3 Y NA NA NA 24
2008 (23) 67 ± 16; Absence ± 3.2 d; Absence of
of stridor: 60 ± 18 stridor: 3.9 ± 3.8 d
Cuff-leak test and extubation

245
ICU = intensive care unit; NA = Not applicable; AC = assistant and control model, VC = volume control model. Time constraints are for investigation after extubation.
Cuff-leak test and extubation T. Zhou et al.

QUADAS
Study characteristics and quality
of reporting

12

10
9
7

10

11
10
5

9
10

5
9
The adult subjects of the included studies varied from the
medical care population to trauma or surgical patients, and

Subgroup
analysis
were thus somewhat heterogenous (Table 1). The aver-
age sample size of the included studies was 201, with a

Yes
Yes
No

No

No
No
No
No

No
No

No

No
No
No
No
No
range of 49–543. We found that the sample size was not
consistent with the number of extubations in four studies

Inter-investigator
(27, 28, 32, 33), suggesting that at least two cuff-leak tests
were performed in the same subject. Participants were tra-

agreement
cheally intubated via the oral or nasal route for a length of
time ranging from less than 24 hours to several days, and

No

No
No
No

No
No
No
No

No
No

No

No
No
No
No
No
were monitored for about 24 or 48 hours after extubation.
All included diagnostic tests were cross-sectional stud-

Prospective
ies (Table 2). Four of 16 trials were approved by Institu-
tional Review Board (IRB), and only one study was reg-

Yes

Yes
Yes
Yes

Yes
Yes
Yes
Yes

Yes
Yes

Yes

Yes
Yes
Yes

Yes
No
istered in public service platform of trial registration (24).
No sample size calculations were applied in any included
study. Subjects who participated in the cuff-leak test were

Blindness

Unclear

Unclear

Unclear
chosen consecutively or at random in 14 of the included

Yes
Yes
Yes

Yes
Yes
Yes

Yes
Yes

Yes
Yes
Yes

Yes
studies. Blinding was used in 12 studies. The average

No
QUADAS score of the methodological quality of studies
was 8.2 whose QUADAS assessment was presented in
Consecutive

Consecutive
Consecutive
Consecutive

Consecutive
Consecutive
Consecutive

Consecutive
Consecutive
Consecutive

Consecutive

Consecutive

Consecutive
or random
Figure 2.

Random

Random
Unclear

No
The cuff-leak test and the threshold effect
Sample size

The included studies used two kinds of methods for the cuff-
calculation

leak test, qualitative (presence or absence of leak around

the tube) and quantitative. The quantitative method, Miller’s
No

No
No
No
No
No

No
No
No

No
No
No
No
No

No
No
test, was proposed by Miller et al. in 1996 (33), and can
be further subdivided into an absolute measure (measured
Cross-sectional

in milliliter volume) and a relative measure (quantified as

percent volume). The cutoff value of the cuff-leak test in
Design

the quantitative method varied from 88–283 ml or 10–57%

Yes
Yes
Yes
Yes

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
in included studies. Regression analysis of the diagnos-
tic threshold found no threshold effect in this systematic
review (all P > 0.05 for both Spearman correlation co-
review
Ethical

Yes

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes

efficient and beta coefficient in Moses’ model) (Data not

No

No
No
No
Table 2 Quality assessment of included studies

shown).
registration

Outcomes for systematic review

Study

Yes
No
No

No
No
No
No
No
No
No
No
No
No

No
No
No

and subgroup analyses

The total incidence of postextubation laryngeal edema was
Sukhupanvarak 2008 (23)

6.79% (95% CI 5.94–7.73%) with a range of 0.60–36.8%,

while the incidence for reintubation secondary to laryngeal
Engoren 1999 (32)

De Bast 2002 (30)

Sandhu 2000 (31)

Erginel 2005 (27)

Cheng 2006 (25)

edema was 3.52% (95% CI 2.79–4.36%) with a range of

Maury 2004 (28)
Fisher 1992 (35)

Kriner 2005 (26)

Marik 1996 (34)
Miller 1996 (33)

Jaber 2003 (29)

Chung 2006 (1)

Wang 2007 (8)

Lee 2007 (24)

Shin 2008 (7)

0.0–10.53% (Table 3). The incidence of postextubation la-

ryngeal edema was 0.57% for less than 24 hours of intuba-
Study

tion, 4.61% for between 24 hours and 5 days, and 16.70%

for more than 5 days.

246 JEBM 4 (2011) 242–254 

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T. Zhou et al. Cuff-leak test and extubation

Representative Spectrum

Selection Criteria

Acceptable Reference Standard

Acceptable Time Period

Partial Ventification Avoided

Differential Verification Avoided

Incorporation Avoided

Index Test Replication

Reference Standard Replication

Index Test Results Blinded

Reference Standard Blinded

Relevant Clinical Information

Uninterpretable Test Results Reported

Withdrawals Explained
Figure 2 Quality assessment in 16
diagnostic tests according to QUADAS 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
items, presented as the proportion of
included studies Yes Unclear No

The subgroup and comparative analyses were based on the
different methods of the cuff-leak test, durations of intuba-
tion, and study populations (Table 4). The heterogeneity was
across Se, Sp, PLR NLR, and DOR. There were increased
medians of specificity, DOR, and AUC for identifying pa-
tients at high risk of postextubation laryngeal edema in the
qualitative method and the absolute volume compared with
the relative volume cuff-leak test, but the sensitivity of the
qualitative method, at 1.00, had a broader range (Figure 3A).
All three methods of the cuff-leak test had similar specifici-
ties for predicting postextubation reintubation, about 0.85
(Figure 3B).
The accuracy of the cuff-leak test varied with different
durations of intubation. There was a higher median speci-
ficity of 0.90, DOR of 69.75, and AUC of 0.92 in predicting
postextubation laryngeal edema in subjects with more than
5 days mean duration of intubation compared with those with
less than 5 days. Furthermore, there was a higher median
specificity of 0.92 and DOR of 37.76 for predicting postex-
tubation reintubation in patients with more than 5 days of
mean duration of intubation.
Multiple regression analysis
QUADAS scores, other quality factors of diagnostic tests,
duration of intubation, and study populations were im-
ported into a meta-regression analysis to assess the ef-
fect of study quality on the DOR of the cuff-leak test
for identifying high-risk patients. The analysis found that
variations of QUADAS, cross-sectional design, consecu-
tive or random, blinding, prospective design, duration of
intubation, and study population did not contribute to the
heterogeneity of ratio of DOR (rDOR) (all P > 0.05)
(Table 5).
Effect of cuff-leak test screening with
prophylactic administration of steroids
on postextubation airway complications
We found no clinical trials in which investigators random-
ized subjects to either take or not take the cuff-leak test. In
six of the studies, patients were divided into three groups
who were treated with either the cuff-leak test screening fol-
lowing by prophylactic administration of steroids in the case
of positive results (the CLT group, n = 686), or steroids or
placebo without cuff-leak test screening (the steroids group,
n = 905 and the placebo group, n = 909). In the CLT group,
only 208 patients (30.3%) had positive cuff-leak test results
[the CLT (positive) group)] and received prophylactic ad-
ministration of steroids. There was no significant difference
in the incidence of postextubation laryngeal edema between
the CLT group and the steroids group (OR = 1.39, 95%
CI 0.79–2.24, P = 0.070). However, the incidence of pos-
textubation reintubation in the CLT group was similar to
that in the placebo group (OR = 0.94, 95% CI 0.32 to
1.57, P = 0.860) (Table 6). According to inference analy-
sis, the mean dose of equivalent methylprednisolone in the
CLT group was much more decreased than that with the
steroids group (34.23 ± 2.20 mg vs 74.23 ± 1.38 mg, P <
0.001).

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c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University 247
248
Table 3 Results of the cuff-leak test in included studies for identifying adult patients at high risk of postextubation airway complications

Subsequent reintubation of laryngeal

Laryngeal edema edema
Cuff-leak Estimates of
Study test type Cutoff optimal cutoffs Incidence (%) TP FP FN TN Incidence (%) TP FP FN TN

Fisher 1992 (35) Qualitative method Presence or absence NA NA NA NA NA NA NA 7 0 0 55

of leak
Marik 1996 (34) One method Presence or absence NA 2.0/100 2 4 0 94 NA NA NA NA NA
Cuff-leak test and extubation

of leak
Miller 1996 (33) Miller’s CLT 110 ml Determined by visual 5.3/95 4 1 1 89 60.0 2 3 1 89
inspection of ROC
curve

JEBM 4 (2011) 242–254 

Engoren 1999 (32) Miller’s CLT 110 ml Determined by visual 0.6/531 0 20 3 508 NA NA NA NA NA
inspection of ROC
curve
Sandhu 2000 (31) Miller’s CLT 10% Determined by 11.8/110 7 2 6 95 46.2 3 6 3 98
sub-group analysis
De Bast 2002 (30) Miller’s CLT 15.5% Determined by visual 13.2/76 NA NA NA NA 80.0 6 19 2 49
inspection of ROC
curve
Jaber 2003 (29) Miller’s CLT 130 ml Determined by visual 11.6/112 11 5 2 94 NA NA NA NA NA
inspection of ROC
curve
Maury 2004 (28) The qualitative Presence or absence NA 3.5/115 4 22 0 89 25.0 1 25 0 89
method of leak
Erginel 2005 (27) Miller’s CLT 283 ml Determined by visual 10.4/67 6 14 1 46 NA NA NA NA NA
inspection of ROC
curve
57% Determined by visual 6 14 1 46 NA NA NA NA NA
inspection of ROC
curve
Kriner 2005 (26) Miller’s CLT 110 ml Refer to Miller 1996 4.3/462 10 72 10 370 35.0 3 79 4 376
15.50% Refer to De Bast 7 41 13 401 2 46 5 409
2002
Chung 2006 (1) Miller’s CLT 140 ml Determined by visual 36.8/95 31 6 4 54 NA NA NA NA NA
inspection of ROC
curve
Cheng 2006 (25) Miller’s CLT 24% Determined by visual 8.10/321 21 107 5 188 57.70 13 115 2 191
inspection of ROC
curve

continued.
T. Zhou et al.

c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
T. Zhou et al. Cuff-leak test and extubation

281
Discussion

NA

NA
TN

85

41
Subsequent reintubation of laryngeal
Postextubation problems such as laryngeal edema and rein-

NA

NA
FN

4
3

0
tubation prolong the need for mechanical ventilation and in-
crease morbidity in intensive care unit patients. In our study,

NA

NA
FP

77
14

8
the incidence of laryngeal edema varied from 0.6–36.8%, and
the reintubation rates secondary to laryngeal edema from

NA

NA
TP

3
8

0
0–80.0%, possibly because of different study populations,
Incidence (%)

severity of diseases, and durations of intubation. We found

that the cuff-leak test accurately identifies adult patients at
edema

high risk of postextubation airway complications, and cuff-

24.1
55.0

80.8
0.0 leak test screening reduces the incidence of postextubation
laryngeal edema but not of reintubation in indirect com-
271

493
parison analysis. We also found that the incidence of pos-
TN

80

80

41

textubation laryngeal edema increased when intubation was

FN

14

22

prolonged.
8

Systematic reviews of interventions sometimes find very

FP

65
10

10

24

similar estimates of the effects of competing interventions

7

CLT = the cuff-leak test; NA = not applicable; TP = true positive; FP = false positive; FN = false negative; TN = true negative.

in different studies, with differences in effects small enough

TP

15
12

11

1
4

to be explicable by chance. However, in test accuracy re-

Laryngeal edema

views large differences are commonly noted among studies,

Incidence (%)

differences too large to be explained by chance, indicating

7.95/365
18.2/110

4.8/543

that actual test accuracy varies among studies, or that there is

2.0/49

heterogeneity in test accuracy. Substantial heterogeneity was

found to be present in our study, so we refrained from pool-
ing and presented median values and ranges instead (37). We
Refer to Miller 1996

Defined by authors

then explored the reasons for the heterogeneity with meta-

The best Youden

The best Youden

optimal cutoffs

regression techniques, but found no clinical heterogeneity.

Estimates of

This indicates that the study design, duration of intubation,

index

index

and study population did not substantially affect the diagnos-

tic accuracy.
NA

The cuff-leak test, a simple method for predicting postex-

tubation airway complications, includes three methods, one
Presence or absence

qualitative and two quantitative. Pettignano et al. (40) demon-

strated that the qualitative cuff-leak test is reproducible and
reliable. We posited that the cuff-leak test quantified in per-
of leak

cent volume would have the highest accuracy among the three
110 ml
Cutoff

88 ml

18%

10%

approaches because height, weight, gender, and other factors

would be adjusted for by this method. However, there were no
reasonable explanations for this finding. The accuracy of the
cuff-leak test for predicting postextubation airway compli-
The qualitative

cations varied among the three different methods. Therefore,

Miller’s CLT
Miller’s CLT

Miller’s CLT

the qualitative method should be used in combination with

method
test type
Cuff-leak

the quantitative method in clinical practice.

The best way to evaluate a diagnostic test is to under-
stand the expected clinical benefits and harms attributable
Sukhupanyarak 2008 (23)

to its use. Integration of systematic reviews of diagnostic

test accuracy and decision making is an emerging area of
Table 3 continued

active research (12, 41). We need to consider the range of

Wang 2007 (8)

potential “threshold probabilities” that should trigger a clin-

Lee 2007 (24)

Shin 2008 (7)

ical decision to initiate treatment (42). Ideally, patients at

high risk of developing postextubation airway complications
Study

should be identified as early as possible. Treatments such as

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c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University 249
250
Table 4 Outcomes of systematic review and subgroup and comparative analyses
Cuff-leak test and extubation

Study characteristic No. of studies Sensitivity Specificity Positive LR Negative LR Diagnostic OR AUC

Laryngeal edema 14 0.80 (0, 1.00) 0.90 (0.64, 0.99) 4.69 (2.23, 72.00) 0.30 (0.13, 0.91) 18.16 (3.54, 356.00) 0.89 ± 0.04
Mean duration of intubation
5 1.00 (0, 1.00) 0.85 (0.80, 0.96) 4.48 (3.07, 18.33) 0.30 (0.13, 0.91) 16.6 (3.54, 105.00)

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≤5 days 0.87 ± 0.06
>5 days 5 0.85 (0.60, 0.89) 0.90 (0.77, 0.99) 8.86 (3.67, 72.00) 0.19 (0.13, 0.45) 69.75 (12.00, 356.00) 0.92 ± 0.05
Study population
Surgical 3 0.54 (0.0, 1.00) 0.96 (0.85, 0.98) 4.90 (3.23, 26.12) 0.47 (0.30, 0.91) 16.60 (3.54, 55.42) 0.92 ± 0.13
Medical 3 0.86 (0.52, 0.89) 0.81 (0.77, 0.90) 3.67 (2.67, 8.86) 0.19 (0.13, 0.60) 19.71 (4.47, 69.75) 0.91 ± 0.06
Surgical and medical 8 0.80 (0.15, 1.00) 0.92 (0.64, 0.99) 4.94 (2.23, 72.00) 0.25 (0.13, 0.89) 23.9 (0.13, 356.00) 0.89 ± 0.05
Qualitative cuff-leak test method 3 1.00 (0.15, 1.00) 0.95 (0.80, 0.96) 4.48 (3.31, 18.33) 0.17 (0.13, 0.89) 35.80 (3.73, 105.00) 0.94 ± 0.05
Quantitative cuff-leak test methods
Absolute volume in cuff-leak 8 0.70 (0.00, 0.89) 0.89 (0.77, 0.99) 4.54 (2.67, 72.00) 0.33 (0.13, 0.91) 31.71 (3.54, 356.00) 0.90 ± 0.05
Relative volume in cuff-leak 6 0.68 (0.35, 1.00) 0.87 (0.64, 0.98) 4.34 (2.23, 26.12) 0.39 (0.19, 0.72) 13.19 (5.27, 55.42) 0.82 ± 0.05
Reintubation 10 0.67 (0.43, 1.00) 0.83 (0.62, 1.00) 3.38 (1.99, 105.00) 0.34 (0.06, 0.73) 10.80 (2.74, 1665.00) 0.82 ± 0.05
Mean duration of intubation
≤5 days 5 0.88 (0.43, 1.00) 0.81 (0.72, 1.00) 3.03 (2.47, 105.00) 0.34 (0.06, 0.69) 9.14 (3.57, 1665.00) 0.80 ± 0.21
>5 days 2 0.70 (0.67, 0.73) 0.92 (0.86, 0.97) 12.79 (5.41, 9.42) 0.33 (0.32, 0.34) 37.76 (16.19, 59.33) –
Study population
Surgical 3 0.50 (0.50, 0.93) 0.94 (0.84, 0.99) 8.67 (3.06, 103.60) 0.53 (0.07, 0.60) 16.33 (5.13, 1540.00) 0.94 ± 0.48
Medical 1 0.43 (0.10, 0.82) 0.78 (0.74, 0.83) 1.99 (0.83, 4.79) 0.73 (0.38, 1.39) 2.74 (0.60, 12.49) –
Surgical and medical 6 0.74 (0.43, 1.00) 0.81 (0.62, 0.97) 3.03 (2.31, 20.44) 0.33 (0.21, 0.69) 10.67 (3.57, 59.33)∗ 0.83 ± 0.04
Qualitative cuff-leak test method 2 1.00 (1.00, 1.00) 0.89 (0.78, 1.00) 54.19 (3.38, 105.00) 0.19 (0.06, 0.32) 114.97 (10.53, 1665.00) –
Quantitative cuff-leak test methods
Absolute volume in cuff-leak 4 0.55 (0.43, 0.73) 0.84 (0.78, 0.97) 3.81 (1.99, 20.44) 0.59 (0.32, 0.73) 9.88 (2.74, 59.33) 0.71 ± 0.30
Relative volume in cuff-leak 5 0.50 (0.29, 0.87) 0.84 (0.62, 0.94) 2.83 (2.31, 8.67) 0.53 (0.21, 0.79) 7.74 (3.56, 16.33) 0.81 ± 0.04

LR = likelihood ratio; OR = odds ratio; AUC = area under curve. With medians and ranges in case of heterogeneity.
T. Zhou et al.

c 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University
T. Zhou et al. Cuff-leak test and extubation

Table 5 Weighted meta-regression of the effects of methodological

quality, duration of intubation, and study population on diagnostic
precision of the cuff-leak test

Covariates Coefficient rDOR (95%CI) P value

Laryngeal edema
QUADAS −0.086 0.92 (0.30, 2.82) 0.858
Cross-sectional design 0.08 1.08 (0.11, 11.05) 0.940
Consecutive or random 0.08 1.08 (0.11, 11.05) 0.940
Blinding 0.244 1.28 (0.03, 57.16) 0.880
Prospective 0.292 1.34 (0.00, 854.09) 0.915
Duration of intubation 0.077 1.08 (0.88,1.33) 0.404
Study population −0.864 0.42 (0.02, 7.41) 0.488
Reintubation
QUADAS −0.204 0.82 (0.51, 1.31) 0.336
Cross-sectional design – – –
Consecutive or random −5.239 0.01 (0.00, 0.98) 0.057
Blinding −0.833 0.43 (0.06, 3.08) 0.338
Prospective – – –
Duration of intubation 0.017 1.02 (0.76, 1.35) 0.892
Study population 0.526 1.69 (0.40, 7.16) 0.406

with positive cuff-leak test results, or at high risk, would

realize much more benefit from prophylactic steroid admin-
istration (2). Furthermore, a recently published study (44)
and another abstract (45) show that the efficacy of steroids
in preventing stridor and reintubation was only observed in a
high-risk population as identified by the cuff-leak test, which
strengthens the effect of the cuff-leak test on predicting pos-
textubation airway complications. Using the GRADE sys-
tem, we found evidence that cuff-leak test screening would
reduce the incidence of postextubation laryngeal edema but
not reintubation. However, this pattern was weaker for trials
in which the comparisons were indirect (46).

Figure 3 Symmetric ROC curves for the cuff-leak test in predicting
postextubation laryngeal edema (A) and reintubation (B). = each
study in the meta-analysis (the size of each study is indicated by the
size of the solid circle); SROC curves summarize the overall diagnostic
accuracy
prophylactic administration of steroids to reduce postextu-
bation airway complications should then be started (3). The
best way to assess any diagnostic strategy is a randomized
controlled trial in which investigators randomize patients to
experimental or control diagnostic approaches and measure
patient-important outcomes (43). There are no trials using
random allocation of the cuff-leak test, but six trials were
identified in which the diagnostic strategies of the cuff-leak
test with prophylactic administration of steroids were com-
pared indirectly. Our previous study suggests that patients
Limitations
Our study has some limitations. First, three different meth-
ods of the cuff-leak test, and prophylactic administration
of steroids with or without the cuff-leak test screening,
were compared indirectly but not head-to-head, which would
decrease the reliability and generalizability of the results.
Second, substantial heterogeneity was found in our study,
so we did not conduct pooled estimates. Third, only one
therapeutic strategy (prophylactic administration of steroids)
was used following a positive cuff-leak test in the included
studies. Fourth, postextubation airway complications such as
laryngeal edema and reintubation secondary to upper airway
obstruction, which were taken as reference standards, were
also patient-important outcomes. What’s more, there is a time
interval between cuff-leak test screening and the occurrence
of patient-important outcomes or reference standards.
In conclusion, our systematic review suggests that the
cuff-leak test accurately identifies patients at high risk of

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Cuff-leak test and extubation T. Zhou et al.

Table 6 Effect of the cuff-leak test on incidence of postextubation airway complications

Laryngeal edema Reintubation

No. of
Groups studies Events Odds ratio (95%CI) NNT P Events Odds ratio (95%CI) NNT P

CLT 2 38/686 1.39 (0.79, 2.24) 53 0.070a 16/686 4.34 (1.59 to11.82) 57 0.002a
CLT (negative) 19/478 1.09 (0.74, 1.44) 305 0.760a 6/478 2.27 (0.00, 4.97) 143 0.162a
CLT (positive) followed by 19/208 0.79 (0.38, 1.20) 42 0.317b 10/208 2.24 (0.51, 3.98) 39 0.306b
steroids
Steroids 4 33/905 0.32 (0.19, 0.44) 13 0.000b 5/905 0.25 (0.01, 0.50) 61 0.003b
Placebo 4 105/909 2.09 (1.28, 2.89) 14 0.000c 20/909 0.94 (0.32, 1.57) 706 0.860c

CLT = cuff-leak test; NNT = number needed to treat; CI = confidence interval. a vs Steroids; b vs Placebo; c vs CLT.

postextubation airway complications, and treating patients Ethics:

with positive test results with prophylactic steroids seems
to reduce the incidence of postextubation laryngeal edema
but not postextubation reintubation. Further randomized con-
trolled trials, in which investigators randomize patients to the
cuff-leak test or a sham test with prophylactic administration
of steroids and measure postextubation airway complica-
tions, are needed to assess this diagnostic strategy.
Funding:
This research was supported by the National Natural Science
Foundation of China (No. 30971326), the Sichuan Youth
Science and Technology Foundation (No. 2010JQ0008), and
the Funding Doctoral Fund of the Ministry of Education of
China (No. 20070610155).
Conflicts of Interest:
Dr. Gang Wang is supported by the National Natural Science
Foundation of China (No. 30971326), the Sichuan Youth Sci-
ence and Technology Foundation (No. 2010JQ0008), Youth
Science Funding of Sichuan University (2011SCU04B17)
and the Funding Doctoral Fund of the Ministry of Edu-
cation of China (No. 20070610155). Dr. Lei Wang is sup-
ported by the National Natural Science Foundation of China
(No. 30901907).
Authorship:
Dr. Gang Wang contributed substantially to the conception
and design of the study; collection, extraction and interpre-
tation of the data; drafting of the manuscript; and statistical
analysis. Drs. Ting Zhou, Hong-ping Zhang, Tao Fan, Juan-
juan Fu, and Wei-wei Chen were responsible for collection,
extraction, and interpretation of the data. Dr. Ze-yu Xiong
was responsible for interpretation of the data and critical re-
vision of the manuscript. Dr. Lei Wang provided insight into
the statistical methods.
This study was designed as a systematic review, so it did not
require ethical approval, but we extracted any ethical review
information from included studies.
Acknowledgments
We are grateful to Ding LW and De Bast Y who sent addi-
tional information on their original studies. We also thank
Profs. Gibson PG. (University of Newcastle, Australia), Van
der Windt DA (Keele University, UK), de Vet HC (VU
University, Amsterdam). Liu GJ (Chinese Cochrane Cen-
ter, China) for their statistics suggestions, and Ms. Ruan R
for her help in preparing this manuscript.
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