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Am J Respir Crit Care Med Vol 164.

pp 225230, 2001
Internet address: www.atsjournals.org

We designed a prospective multicenter randomized controlled
study in three long-term weaning units (LWU) to evaluate which
protocol, inspiratory pressure support ventilation (PSV) or sponta-
neous breathing trials (SB), is more effective in weaning patients
with chronic obstructive pulmonary disease (COPD) requiring me-
chanical ventilation for more than 15 d. Fifty-two of 75 patients,
failing an initial T-piece trial at admission, were randomly assigned
to PSV or SB (26 in both groups). No significant difference was
found in weaning success rate (73% versus 77% in the PSV and SB
group, respectively), mortality rate (11.5% versus 7.6%), duration
of ventilatory assistance (181


161 versus 130


106 h), LWU (33


12 versus 35


19 d), or total hospital stay. The results of these de-
fined protocols were retrospectively compared with an uncon-
trolled clinical practice in weaning historical control patients. The
overall 30-d weaning success rate was significantly greater (87%
versus 70%) and the time spent under mechanical ventilation by
survived and weaned patients was shorter in the patients in the
study than in historical control patients (103


144 versus 170


127 h). The LWU and hospital stays were also significantly shorter
(27


12 versus 38


18 and 38


17 versus 47


18 d). Spontane-
ous breathing trials and decreasing levels of PSV are equally effec-
tive in difficult-to-wean patients with COPD. The application of a
well-defined protocol, independent of the mode used, may result
in better outcomes than uncontrolled clinical practice.

Endotracheal intubation and mechanical ventilation are often
needed in patients with chronic obstructive pulmonary disease
(COPD) and acute respiratory failure who may undergo diffi-
culties in the weaning process and related need of tracheos-
tomy.
A recent review of the literature (1) of patients in general
intensive care units (ICUs) (a minority with COPD) was un-
able to identify a superior weaning technique among the three
most popular modes (T-piece, synchronized intermittent man-
datory ventilation [SIMV], or pressure support ventilation
[PSV]) (2, 3). Furthermore recent trials have demonstrated
that simply introducing a protocol or guideline for the wean-
ing process leads to a decrease in weaning time independent
of the mode used (4, 5).
Similar studies have not been performed in a long-term
weaning unit (LWU) setting yet, nor have studies been specif-
ically dedicated to patients with COPD. These patients are
characterized by a different response to ventilator disconnec-
tion and weaning compared with patients in acute settings.
Therefore results of studies performed in the acute setting in
patients without COPD cannot be applied to difficult-to-wean
patients with COPD.
A better knowledge of the best weaning modality could
help improve the general management of such patients and,
ultimately, lead to a greater rate of discontinuation of mechani-
cal ventilation and closure of the tracheostomy with reduced
need of home ventilation and reduced human and financial
costs (6). Therefore, we designed a prospective, randomized
multicenter study to identify which modality (if any), sponta-
neous breathing (SB) trials or decreasing levels of PSV, is su-
perior in weaning tracheostomized patients with COPD re-
quiring mechanical ventilation for more than 15 d. As a
secondary end point, we also performed a retrospective com-
parison with historical control patients to determine whether a
well-defined protocol, independent of the mode used, is more
effective than uncontrolled clinical practice in weaning.

METHODS

Patients

We studied 75 consecutive tracheostomized difficult-to-wean patients
with COPD (7), mechanically ventilated for at least 15 d (range 15
39) and transferred from 24 ICUs of other hospitals to three long-
term weaning units (LWUs).

Retrospective study

. Fifty-five prospectively studied patients from
one LWU (Gussago) were retrospectively compared with 62 patients
admitted to the same LWU in the 2 yr preceding the study. In this
LWU, those patients had undergone an uncontrolled clinical practice
of weaning (4, 5). Comparability parameters were location, age, ideal
body weight (IBW), arterial blood gases under mechanical ventila-
tion, and the Acute Physiology and Chronic Health Evaluation
(APACHE) II score (8) within 24 h of admission to the LWU.

Measurements

The following data were recorded at admission: anthropometrics, activ-
ity of daily life (ADL) scale (9), and location prior to ICU admission;
number of hospitalizations in the year before the study and referral;
ICU length of stay; APACHE II score; and presence of pneumonia at
admission to the LWU.
Lung function data in the last stable state before ICU admission or
assessed at discharge from the LWU and maximal inspiratory pres-
sure (MIP) during the first 5 min of the T-piece trial (10) were also re-
corded.
Breathing pattern (tidal volume [V

T

], respiratory frequency [f

R

])
and minute ventilation (

E

) under mechanical ventilation were moni-
tored through the ventilator display.

Protocol

Before the T-piece trial, medical therapy was optimized, and patients
airway secretions were frequently suctioned. The patients were venti-
lated with an inspiratory pressure support (19


3 cm H

2

O) adjusted
V


(

Received in original form August 29, 2000 and in revised form November 27, 2000

)
Correspondence and requests for reprints should be addressed to Michele Vi-
tacca, M.D., Fondazione S. Maugeri IRCCS, Istituto Scientifico di Gussago, Via
Pinidolo 23, 25064 Gussago (BS) Italy. E-mail: mvitacca@fsm.it
This article has on online data supplement, which is accessible from this issues
tabel of contents online at www.atsjournals.org

Comparison of Two Methods for Weaning Patients
with Chronic Obstructive Pulmonary Disease
Requiring Mechanical Ventilation for
More Than 15 Days

MICHELE VITACCA, ANDREA VIANELLO, DANIELE COLOMBO, ENRICO CLINI, ROBERTO PORTA, LUCA BIANCHI,
GIOVANNA ARCARO, GIOVANNI VITALE, ENRICO GUFFANTI, ALBINO LO COCO, and NICOLINO AMBROSINO

Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Gussago, Lung Function Unit, Gussago, Italy; Ospedale Civile, Padova, Italy;
INRCA Casatenovo, Italy; and Ospedale Civico, Palermo, Italy

226

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL 164 2001

to achieve pH


7.35, arterial oxygen saturation (Sa

O

2

)


92%, f

R



10 and


25 breaths/min, and inspiratory oxygen fraction (F

I
O

2

)


0.4.
An external positive end-expiratory pressure (PEEP)


6 cm H

2

O (4


1 cm H

2

O) was added when intrinsic PEEP (PEEP

i

) was suspected on
a clinical basis.

T-piece trial

. Patients were eligible to T-piece trial if they fulfilled
the conditions previously reported (4, 11): the T-piece trial was con-
sidered unsuccessful if during 48 h of SB, the patient showed any sign
of poor tolerance (4, 11).

Randomization

. All patients failing the T-piece trial were ran-
domly assigned to receive PSV or SB trials according to modified pro-
tocols by Brochard and coworkers (3) with the ventilator set to re-
quire the lowest patient effort to initiate a mechanical ventilator
breath.
For the purposes of the study, patients of both groups were consid-
ered as successfully weaned when able to tolerate at least 48 consecu-
tive h of SB. Patients completing all the levels of either the PSV or SB
trial (2), but showing poor tolerance to SB within 48 h of ventilator
disconnection, were reconnected to the ventilator for at least 8 con-
secutive h. Thereafter, the protocol was reinstituted starting from the
lowest tolerated level of PSV or from the longest tolerated duration
of SB.

Weaning Outcomes

The following parameters were recorded and compared in the two
groups and, in the retrospective study, in the study population and the
historical control patients: initial T-piece trial success rate, 10- and
30-d weaning success rate, time of weaning, LWU, and hospital length
of stay. Failure was a patient who died or who still needed mechanical
ventilation after at least 30 consecutive days of weaning protocol.

Statistical Analysis

Statistical analysis, as well as other additional M

ETHODS

sections, is shown
in the online data supplement to this article at www.atsjournals.org.

RESULTS

Prospective Study

During the study period 114 patients were admitted to the
three LWUs. Thirty-seven patients (15 with postcardiosurgical
sequelae, 9 neuromuscular, 9 neurological, and 4 with acute
respiratory distress syndrome [ARDS]) did not have COPD.
Two patients with COPD were excluded from the study due to
concomitant cancer.

Randomization

. Twenty-three of the 75 eligible patients
(31%) had a successful early T-piece trial and were excluded
from randomization. Fifty-two (69%) patients failed the
T-piece trial after a mean time of 290


452 min (median: 120
min, range: 152145 min) and were randomly assigned to ei-
ther the PSV or SB group (26 patients in each group). Figure 1
shows the trial profile.
The anthropometric, functional, and clinical characteristics
of the two groups can be accessed in the

Journals

online re-
pository. There were no significant differences in anthropo-
metrics, lung function in stable state, clinical severity at admis-
sion, breathing pattern,

E

, and arterial blood gases under
mechanical ventilation at randomization and MIP at the
T-piece trial. As shown in Table 1, the two groups were not
different as to location, ADL, hospitalizations in the year pre-
ceding ICU admission, and length of ICU stay before LWU
admission. Comorbidities were present in 13 patients in the
PSV and 15 in the SB group. In the PSV group, the patholo-
gies were pneumonia (5 patients), arterial hypertension (10),
arrhythmia (2), congestive heart failure (1), and diabetes (5).
In the SB group, the pathologies were pneumonia (2), arterial
hypertension (11), arrhythmia (1), congestive heart failure (2),
and diabetes (7). Differences were not significant.
V


Outcomes

. Figure 2 shows the percentage of patients who
were unable to be weaned from mechanical ventilation (i.e.,
patients who died and patients who failed to be weaned after
30 d) in both modes of weaning. No significant differences
Figure 1. Patient distribution.

TABLE 1. CLINICAL STATUS PRIOR TO ICU ADMISSION*

PSV SB
Location prior to ICU, patients, n
Home 26 26
Length of ICU stay before LWU
admission, d
25


9 27


17
Length of ICU stay before LWU
admission, patients, n
Days
17 0 0
815 2 0
1623 14 13
2431 6 4



32 4 9
ADL, patients, n
Level of disability
None 3 2
Moderate 14 12
Severe 9 12
Year hospital admissions before ICU,
patients, n
Admissions, n
0 7 8
1 8 10
2 6 4


2 5 4

Definition of abbreviations

: ADL


activity of daily life; ICU


intensive care unit; LWU


long-term weaning unit; PSV


pressure support ventilation; SB


spontaneous
breathing.
* Data are mean


SD. No difference was significant.

Vitacca, Vianello, Colombo,

et al.

: Weaning COPD Patients Requiring Mechanical Ventilation 227

were found between the groups either at 10 d (probability of
remaining under mechanical ventilation


35% and 31% for
the PSV and SB groups, respectively) or at 30 d (27% versus
23%) after the start of the protocol.
Although patients in the PSV group weaned and survived,
and spent more hours on mechanical ventilation than those in
the SB group (181


161 versus 130


106 h, respectively), the
difference was not significant. The two groups showed similar
LWU (33


12 versus 35


19 d for the PSV and SB groups,
respectively) and total hospital stay (49


27 versus 50


32 d).
None of the 39 successful patients from the combined groups
needed reinstitution of mechanical ventilation after the final
48 h. Three of 26 patients (11.5%) from the PSV group and
two patients (7.6%) from the SB group died within the first 30
d of protocol application. All deaths were due to multiple or-
gan failure and were not considered related to prolonged me-
chanical ventilation. Four patients in each group failed at-
tempts at weaning and therefore were discharged home with
long-term invasive mechanical ventilation. Three of these
eight patients died in the 3 mo following hospital discharge.
Five of the 39 (13%) subjects from both groups who survived
and were weaned died in the 3 mo following hospital dis-
charge. In 45 of the overall 62 weaned patients (72%), tra-
cheostomy was closed before hospital discharge.
Table 2 shows the anthropometric, clinical, and physiologi-
cal characteristics of the patients from the PSV and SB groups
combined according to weaning success or failure. Patients
failing weaning underwent more hospitalizations in the year
before ICU admission, had a greater limitation in ADL, spent
more time in the referring ICUs, and had lower inspiratory
muscle strength during the initial T-piece trial. Stepwise dis-
criminant analysis showed that hospitalizations in the preced-
ing year, MIP, severity of airway obstruction (FEV

1

/FVC) in a
stable state, days spent in the general ICU, and IBW, in that
order, separated weaned patients from those not weaned.

Complications

. New pneumonias were diagnosed in three
patients in the PSV group and in two patients in the SB group;
new arrhythmias were found in three patients in the PSV
group and three patients in the SB group; agitation needing
low dose sedative (benzodiazepine, morphine) was found in
seven patients in the PSV group and three patients in the SB
group. Differences were not significant.

Retrospective Study

As shown in Table 3, the 55 eligible patients and the 62 histor-
ical control patients from the Gussago LWU were not differ-
ent as to comparable parameters and severity of airway ob-
struction in a stable state, ADL, yearly hospital admissions
before ICU, breathing pattern, minute ventilation, and heart
rate under ventilatory assistance.
Figure 3 shows the retrospective comparison of the per-
centage of patients who were unable to be weaned from me-
chanical ventilation (deaths and failure to be weaned after 30
d) with and without the use of a prefixed weaning protocol in-
cluding the initial T-piece trial. The overall 30-d weaning suc-
cess rate (probability of remaining under mechanical ventila-
tion


87% versus 70%, respectively, p


0.01) was greater
and the time spent under mechanical ventilation by survived
and weaned patients was shorter (103


144 versus 170


127 h,
p


0.0001) in the patients in the study than in the historical
controls. The LWU (27


12 versus 38


18 d) and hospital

TABLE 2. CHARACTERISTICS OF PATIENTS IN STUDY ACCORDING
TO WEANING SUCCESS OR FAILURE*

Success Failure p Value
Patients, n, % 39 (75%) 13 (25%)
Time of T-piece failure, min 343


505 115


93 0.11
Age, yr 71


5 74


5 0.57
IBW, %


91


11 85


11 0.14
FEV

1

, % pred


33


8 23


5 0.15
FVC, % pred


43


10 34


9 0.54
Pre-ICU year hospitalization, n 1.5


0.7 2.8


0.7 0.005
ADL, n patients (%)
None 4 (10) 0 (0) 0.17
Moderate 24 (63) 2 (15) 0.001
Severe 11 (27) 11 (85) 0.001
ICU stay before LWU, d 23


6 35


24 0.03
APACHE II


16


4 18


4 0.69
Pa

O2

/F

I
O
2


217


65 219


62 0.38
Pa

CO
2

, mm Hg


55


10 55


11 0.10

E

, L/min


3 6


2 0.65
f

R

/V

T


84 60 0.32
MIP, cm H

2

O


37


11 26


7 0.005
Pneumonia, n patients (%) 8 (20) 4 (31) 0.32
Arrythmia, n patients (%) 8 (20) 1 (8) 0.29
Agitation, n patients (%) 7 (18) 3 (23) 0.68

Definition of abbreviations

: ADL


activity of daily life; APACHE


Acute Physiology and
Chronic Health Evaluation; F

I

O
2



fraction of inspired oxygen; f

R



respiratory frequency;
IBW


ideal body weight; ICU


intensive care unit; LWU


long-term weaning unit;
MIP


maximal inspiratory pressure;

E



minute ventilation; V

T



tidal volume.
* Data are mean


SD.


Historical data or assessed at hospital discharge.


Recorded at admission.


Recorded under mechanical ventilation at randomization.


Assessed during the first 5 min of T-piece trial.
V

Figure 2. KaplanMeier curves of probability of remaining


under mechanical ventilation for patients survived and weaned
performing the fixed protocol (solid circles) or having under-
gone uncontrolled clinical practice (open circles). Differences
were significant (p 0.0001).
228 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL 164 2001
(38 17 vs 47 18 d) stays were also shorter in the patients
weaned with the fixed protocol in the study than in the histori-
cal control patients.
DISCUSSION
Our study shows that spontaneous breathing trials and de-
creasing levels of inspiratory pressure support are equally ef-
fective in weaning tracheostomized patients with COPD un-
dergoing mechanical ventilation for more than 15 d. By means
of an historical comparison, this study also shows that the ap-
plication of a well-defined protocol, independent of the mode
used, is associated with greater weaning success rate, shorter
time under mechanical ventilation, and shorter LWU and hos-
pital stay than uncontrolled clinical practice.
It is estimated that 1% to 5% of mechanically ventilated
patients repeatedly fail attempts at weaning from mechanical
ventilation and face a substantial risk of becoming chronic
ventilator-dependent patients who cannot sustain SB for more
than a few hours (6). This proportion increases to as much as
31% to 56% in some LWUs where difficult-to-wean patients
are located (6, 12). Studies of predictors, protocols, and spe-
cific weaning strategies have been largely confined to patients
intubated for short periods of time (24, 13). A recent review
of the literature (1) on weaning techniques used in intubated
patients with different etiologies (a minority with COPD) ad-
mitted to general ICUs was unable to identify a superior wean-
ing technique between the two modalities used in our study
(namely SB trials and reducing levels of inspiratory pressure
support) (2, 3). Similar studies have not been performed yet in
an LWU setting, nor have studies been specifically dedicated
to patients with COPD. These patients are considered to be
the most difficult to wean from the ventilator (3). The major
mechanism underlying the need for prolonged mechanical
ventilation in patients with COPD has been reported to be the
association between abnormal lung mechanics, in particular
PEEP
i
, lung resistances, and reduced pressure-generating ca-
pacity of the inspiratory muscles because of pulmonary hyper-
inflation (14). Data from the general ICUs in patients with
acute respiratory failure from etiologies other than COPD
cannot be extrapolated to patients with COPD requiring pro-
longed mechanical ventilation in an LWU. Our study is the
first to evaluate the effectiveness of the most popular modali-
ties of weaning patients with COPD undergoing prolonged
mechanical ventilation (more than 15 d). Despite the small
sample size, our study seems to confirm findings reported in
acute patients (2, 3) and in difficult-to-wean patients with
COPD.
Recent trials performed on general populations of ICU pa-
tients (only a minority with COPD) (4, 5, 15) have demon-
strated that simply introducing a protocol or guideline to the
weaning process leads to a decrease in weaning time, indepen-
dent of the mode used. The results of our retrospective com-
parison suggest that the application of a fixed weaning proto-
TABLE 3. ANTHROPOMETRIC, CLINICAL, AND FUNCTIONAL
CHARACTERISTICS OF PATIENTS IN THE RETROSPECTIVE STUDY
Prospective
Group
Retrospective
Group p Value
Subjects, n 55 62
Age, yr 71 5 73 5 0.58
IBW, %* 90 10 91 5 0.55
APACHE II

15 3 16 3 0.08
pH

7.40 0.04 7.41 0.05 0.60


Pa
CO
2
, mm Hg

54 9 56 8.9 0.25
Pa
O2
/FI
O
2

225 48 214 74 0.23


FEV
1
/FVC,%* 47 8 48 9 0.38
ADL, n (%) of patients
None 3 (5) 6 (10) 0.39
Moderate 27 (50) 30 (49) 0.40
Severe 25 (45) 25 (41) 0.69
Year hospital admissions before ICU, n
(%) of patients
0 6 (11) 11 (18) 0.40
1 27 (49) 24 (39) 0.50
2 8 (15) 7 (12) 0.68
2 14 (25) 19 (31) 0.46
ICU stay before LWU admission, d 23 17 26 9 0.11
fR breaths/min

20 6 21 4 0.11
VT, ml

396 149 400 100 0.50


E, L/min

8.1 2.5 8.6 1.4 0.16


Heart rate, beats/min

96 18 99 16 0.26
MIP, cm H
2
O

38 10 32 6.6 0.01
Definition of abbreviations: ADL activity of daily life; APACHE Acute Physiology and
Chronic Health Evaluation; FI
O
2
fraction of inspired oxygen; fR respiratory frequency;
IBW ideal body weight; ICU intensive care unit; LWU long-term weaning unit;
MIP maximal inspiratory pressure; E minute ventilation; VT tidal volume.
* Historical data (53% and 55% for prospective and retrospective groups, respec-
tively) or assessed at hospital discharge under tracheostomy (47% and 45% for pro-
spective and retrospective groups, respectively).

At admission to LWU.

Under mechanical ventilation within 24 h of admission to LWU.

During the first minutes of T-piece trial.


V

Figure 3. KaplanMeier curves of probability of mechanical


ventilation for the 52 randomized patients according to the
two techniques studied. There was no significant difference
between the two groups (solid circles, PSV group; open circles,
SB group).
Vitacca, Vianello, Colombo, et al.: Weaning COPD Patients Requiring Mechanical Ventilation 229
col, in the conditions and in the patients of this study, may
increase the weaning success rate and reduce the time spent
under mechanical ventilation in patients with COPD venti-
lated for more than 15 d. These results must be considered
with caution. Although there was no change in staffing or in
attitude of staff over time, an effect of time differences be-
tween the two weaning periods rather than the protocol itself
cannot be excluded, and further randomized, prospective
studies must confirm our results. Reducing the proportion of
ventilator-dependent patients to be discharged with home me-
chanical ventilation and their LWU stay might have relevant
social and economic consequences.
Another important result of our study is that 31% of tra-
cheostomized patients with COPD referred to an LWU for
prolonged weaning may be disconnected from the ventilator
after an early T-piece trial without any need for a further wean-
ing process. In the acute setting, Saura and coworkers (15) re-
ported that following the implementation of a weaning proto-
col, there was a greater number of patients extubated without
any weaning technique; that is, the initial SB trial was the most
important factor. Thus, at least in the conditions of our study,
an early T-piece trial should be recommended in these diffi-
cult-to-wean patients with COPD (16).
Although a recent ICU study suggests that a 30-min wean-
ing trial may be as good as a longer 120-min trial in predicting
successful weaning (17), another study on a large population
pointed out that short trials bear a high risk of reintubation
rate (13). Our data demonstrate that this short time cannot be
extrapolated to tracheostomized patients with COPD: in fact
our patients from both groups failed the T-piece trial after a
period of apparent stability longer than reported in studies in
an acute setting (13, 17). At variance with studies in the ICU
(18, 19), Purro and coworkers (14), in LWU patients similar to
ours, did not find any significant change in breathing pattern,
neuromuscular drive, inspiratory muscle strength, lung me-
chanics, PEEP
i
, and lung resistances between the beginning
and the end of the SB trial, independent of weaning success.
However, they found a progressive increase in Pa
CO
2
at the
end of the SB period indicating that the SB pattern was not ef-
ficient in terms of CO
2
elimination and that the ventilatory
pump was not coping with the metabolic demand (20). This
may be confirmed by the fact that in our study MIP was lower
in the unweanable patients than in those successfully weaned.
Similar results had also been found by Nava and coworkers (21).
Fourteen or 21 d is commonly considered the time limit to
judge a patient as difficult to wean and to perform tracheos-
tomy in the ICU (1). Patients considered unweanable re-
quire intensive nursing (22), physiotherapy, counseling, and
nutritional and psychological support before being judged as
ventilator-dependent patients and discharged home under
mechanical ventilation. Dasgupta and coworkers (23) showed
that 60% of the patients considered unweanable at the time
of ICU discharge regained respiratory autonomy after a rela-
tively short (mean: 17 d) stay in a specialized respiratory care
unit. Our study confirms and extends those data in that more
than 80% of patients with COPD admitted to an LWU for
prolonged weaning may be restored to SB after a mean time
of 28 11 d of LWU stay. This is a success rate superior to
that previously reported (24, 25). Nevertheless, in our LWUs,
weaning success rates at 10 and 30 d of all eligible 75 patients
were not significantly different (77% and 83%, respectively),
the success rate at 30 d increasing by only 6%. Whether this
difference makes it worthwhile to prolong the weaning at-
tempts to 30 d with related greater costs and LWU stay re-
mains to be evaluated by specific studies on a greater number
of patients.
Limitations of the Study
Our results are limited by the small sample size, which might
have influenced the lack of statistical differences between the
two interventions (assuming clinically relevant a 20% differ-
ence in the rate of weaning between SB and PSV, for a Type I
error 0.05 and for a Type II error 0.20, the required
sample size for a two-tailed comparison would be 90 subjects
for each group). Nevertheless, our results showed the com-
plete absence of any trends for a difference, and, therefore, we
can speculate that it is unlikely that a significant difference
would emerge, even with substantially larger numbers.
A potential influence of the specific weaning protocol on
the rates of weaning success on the first days cannot be ruled
out. Indeed limitations on the number of reductions in PSV
level or length of SB trials per day might have resulted in
more similar rates of weaning. Nevertheless, although this
may have affected the initial portions of the KaplanMeier
curves, it should not have influenced 30-d weaning rates.
In conclusion, we have shown that in difficult-to-wean pa-
tients with COPD spontaneous breathing trials and decreasing
levels of inspiratory pressure support are equally effective in
weaning success rate and weaning time. With the limitations
of an historical comparison, we have also shown that a well-
defined protocol, independent of the modality used, was asso-
ciated with a better outcome than uncontrolled clinical prac-
tice previously performed in the LWU. Nevertheless, further
randomized, prospective studies on a larger number of pa-
tients are required to confirm our results.
Acknowledgment: The authors thank Prof. Laurent Brochard for useful dis-
cussion and comments.
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