Journal of Critical Care (2012) 27, 549–555

A weaning protocol administered by critical care nurses for

the weaning of patients from mechanical ventilation☆
Jae Hyung Roh MD, Ara Synn RN, Chae-Man Lim MD, FCCM, Hee Jung Suh RN,
Sang-Bum Hong MD, Jin Won Huh MD, Younsuck Koh MD, FCCM ⁎
Department of Pulmonary and Critical Care Medicine, University of Ulsan, College of Medicine, Asan Medical Center,
Seoul, South Korea

Keywords:
Abstract
Ventilator weaning;
Purpose: The primary objective of this clinical trial of patients on mechanical ventilation was to
Nurse;
determine if a weaning protocol implemented solely by nurses could reduce the weaning time relative to
Mechanical ventilator;
usual care (UC).
Weaning protocol
Materials and Methods: This study is a prospective, randomized, controlled trial conducted from
January 2007 to January 2009 that compared protocol-based weaning (PBW) with UC. A total of 122
patients who received invasive ventilation in the medical ICU of the Asan Medical Center were
examined. Nurses operated the mechanical ventilators according to a predesigned ventilator-weaning
protocol for the PBW group (n = 61), and intensive care unit (ICU) physicians managed weaning in the
UC group (n = 61).
Results: There were no significant differences in the 2 groups at baseline. The number of patients who
successfully discontinued mechanical ventilation was similar in the 2 groups (PBW, 46 patients, 75.4%;
UC, 47 patients, 77.0%; P = .832). The weaning time was 47 hours (interquartile range, 24-168 hours)
in the UC group and 25 hours (interquartile range, 5.75-134 hours) in the PBW group (P = .010).
Conclusions: The weaning protocol administered by the nurses was safe and reduced the weaning time
from mechanical ventilation in patients who were recovering from respiratory failure.
© 2012 Elsevier Inc. All rights reserved.

1. Introduction barotraumas. In particular, only 10% of intensive care unit

The use of mechanical ventilation is often lifesaving but is
also associated with significant health care costs and serious
complications, such as ventilator-associated pneumonia and
☆ to reduce the duration of mechanical ventilation. Many
Conflict of interest: all the authors involved in this study have no
conflicts of interest to disclose.
⁎ Corresponding author. Tel.: +82 2 3010 3134; fax: +82 2 3010 4709.
E-mail address: yskoh@amc.seoul.kr (Y. Koh).
(ICU) patients require more than 3 weeks of mechanical
ventilation, and only 9% to 20% of patients who require
mechanical ventilation require this support for more than 3
weeks, although these patients use approximately 50% of
ICU resources [1]. Thus, there have been significant efforts
studies of ventilator-weaning protocols have reported
reduced weaning times in patients weaned by a defined
protocol rather than usual care (UC) [2-7].

0883-9441/$ – see front matter © 2012 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.jcrc.2011.11.008
550
Previous studies of weaning protocols indicated that the
results depend on the environment in which the protocol is
administered. For example, Krishnan et al [8] concluded that
protocol-directed weaning may be unnecessary in a closed
ICU with significant physician staffing and structured
rounds. However, most hospitals in Korea and in developing
countries do not have full-time intensivists in their ICUs, and
mechanical ventilators are mainly operated by physicians
who were initially assigned to patients on the in-patient floor.
The weaning times under these circumstances may be
prolonged if the physician is unfamiliar with the weaning
process or if the physician's schedule does not allow time to
respond to individual patient needs. In addition, most
hospitals in Korea and in developing countries have less
advanced physician staffing pattern and limited numbers of
respiratory therapists at ICUs to help with implementation of
the weaning protocol [2-8]. Although, because these
differences between developing and developed countries,
the amount of the effect of weaning protocol is expected to
be different, there has been no prospective randomized
studies of the effectiveness of weaning protocol in hospitals
with limited resources.
Rotello et al [9] concluded that a nurse-directed oxygen
weaning protocol that used a combination of a single arterial
blood gas analysis and multiple pulse oximetry measure-
ments was safe, reduced the need for arterial puncture, and
decreased the duration of oxygen weaning time to fraction of
inspired oxygen (FIO2) of 50% or less. Thus, it appears that
nurses can successfully wean patients from mechanical
ventilation using well-defined protocols and can expedite the
weaning process because they are more readily available
than physicians and respiratory therapists.
On these background, we customized the weaning
protocol used in previous study [6] for our domestic needs
and designed randomized controlled trial, the intervention
arm of which was intended to simulate other hospitals that
had less human resources by not allowing physicians and
respiratory therapists to operate the mechanical ventilator
and make decision about weaning process. Then we
compared the efficacy of protocol-based weaning (PBW)
delivered by ICU nurses with UC provided by ICU
physicians in the patients who had recovered from the
illness that caused respiratory failure.
2. Materials and methods
2.1. Patient characteristics
The study population consisted of patients admitted to the
medical ICUs of the Asan Medical Center (AMC; Seoul,
Korea), a tertiary academic medical center with 2680 beds,
between January 2007 and January 2009. During the study
period, 138 eligible patients were admitted to the study unit,
and 122 patients (89 men and 33 women) were ultimately
enrolled. All enrolled patients had PaO2/FIO2 of at least 200,
J.H. Roh et al.
had respiratory volume of 15 L/min or less, had stable vital
signs, and did not use vasopressors. Patients who were 18
years and younger or 90 years and older, were on mechanical
ventilation for 12 hours or less or 14 days or more, were on
noninvasive ventilation, or had do-not-resuscitate orders
were excluded (Table 1).
2.2. Randomization
A computerized randomization scheme was used for
group assignment at enrollment, and each assignment was
indicated on a data form that was folded and sealed in an
opaque envelope. The envelope was opened only after
written informed consent, mostly provided by relatives
because the patients were sedated. Each patient was enrolled
by a fellow in pulmonary medicine or critical care who was
not involved in the patient's routine care. Enrollment and
randomization led to assignment of 61 patients to the PBW
group and 61 patients to the UC group.
2.3. Study protocol
The institutional review board of the AMC approved the
study protocol. The charge nurse screened mechanically
ventilated patients in the medical ICU every morning, and
eligible patients were randomly assigned to the PBW or UC
group. The weaning protocol used in this study was
developed according to local needs in Korea and was
based on a previous study [6] and the guidelines of acute
respiratory distress syndrome (ARDS) net [10] (Fig. 1). A
pilot study of 72 patients indicated that this protocol was safe
and effective in reducing the weaning time from mechanical
ventilation. During the study period, there were no
complications related to the weaning protocol [11].
For patients randomized to the PBW group, the
mechanical ventilator was entirely operated by nurses.
Nurses could control FIO2, level of positive end-expiratory
Table 1 Inclusion and exclusion criteria
Inclusion criteria
PaO2/FIO2 N200 mm Hg
Minute ventilation b15 L/min or (b 200 mL/(kgmin))
Age within the range from 18 to 90 y
pH measured in arterial blood N7.3
Serum potassium within the range from 3 to 5 mmol/L
Serum sodium within the range from 128 to 150 mmol/L
Hemoglobin measured in whole blood N7 g/dL
Exclusion criteria
DNR (do-not-resuscitate)
Ventilatory support b12 h or N14 d
On noninvasive ventilation
Any of following criteria
1. Active bleeding
2. Known or suspected increased intracranial pressure
Wearing protocol for patients from mechanical ventilation
Fig. 1 Ventilator weaning protocol. A/C mode indicates assist/control mode; CPAP, continuous positive airway pressure; PEEP, positive
end-expiratory pressure; PS, pressure support; PSV, pressure support ventilation; RR, respiratory rate.
pressure (PEEP), and inspiratory pressure for 24 hours.
Continuous positive airway pressure trials, spontaneous
breathing trials, and extubations were only allowed from
07:00 to 17:00. Extubation was only performed by physicians
when a nurse reported a patient's readiness for extubation,
and the physician monitored the patient for 30 minutes
afterward. When a patient's condition deteriorated because of
an event, such as aspiration, sepsis, or obstruction of artificial
airways, the physician in charge operated the mechanical
ventilator. After recovery from a deteriorated condition, when
the patient's status again met the inclusion criteria, nurses
operated the mechanical ventilator. A patient's relatives and
the physician in charge could disallow a nurse from operating
the mechanical ventilator at any time. Such events occurred in
3 patients, and their medical records were reviewed after the
study period. The causes for discontinuation in 2 patients
were not identified, but the patients successfully weaned from
mechanical ventilators and were ultimately discharged. The
other patient developed sepsis during the study period.
Although physicians operated this patient's ventilator, he
551
ultimately died. During the study period, there were no
complications related to the study protocol.
The operation of the mechanical ventilator in the UC group
was entirely at the discretion of the medical resident physicians,
who were under the full-time supervision of critical care
physicians. Except for the researchers, the physicians were
blinded to the protocol used in the PBW group.
The medical ICU at the AMC is a closed 28-bed unit
staffed by 3 attending physicians, 2 ICU fellows, and 6
medical residents in their second or third years. The
physicians work in 3 teams, each with 3 or 4 physicians.
All physicians attend structured twice-daily bedside rounds
that last approximately 2 hours. The decisions about
management of mechanically ventilated patients are based
on electronic templates and medical records that cover each
major physiologic system and are completed daily by the
house staff and charge nurses. Most physicians remain in the
ICU for their entire working hours, and 2 house officers stay
overnight. All nurses are registered nurses, and the nurse-to-
patient ratio was 1:2.5, plus 4 additional senior nurses. Two
552 J.H. Roh et al.

respiratory therapists were involved in the management of Table 2 Baseline patient characteristics of the PBW and
mechanically ventilated patients. UC groups
Characteristic PBW UC P
2.4. Outcomes (n = 61) (n = 61)
Age (y), mean ± SD 64.2 ± 13.0 63.4 ± 13.3 .721
The primary outcome was weaning time, defined as the Female (%) 19 (31.1) 14 (23.0) .308
time from enrollment and randomization, which meant that Routes of admission (%) .362
weaning from the mechanical ventilator was initiated and the Emergency department 27 (44.3) 30 (49.2)
condition causing respiratory failure had been treated, to In-patient floor 34 (55.7) 29 (47.5)
successful discontinuation of mechanical ventilation. Patients Other ICU 0 2 (3.3)
were classified as successfully weaned if they were able to Reasons for initiating .132
breathe unassisted for 48 hours at their first spontaneous mechanical
ventilation (%)
breathing trial. The secondary outcomes were overall
Acute exacerbation 10 (16.4) 14 (23.0)
duration of mechanical ventilation, duration of stay in the of chronic respiratory
ICU, duration of hospitalization, and frequency of compli- disease
cations (tracheostomy, failure of discontinuation, death). Postoperative state 6 (9.8) 1 (1.6)
Pulmonary edema 3 (4.9) 6 (9.8)
2.5. Statistical analysis Pneumonia 25 (41.0) 21 (34.4)
Sepsis 15 (24.6) 12 (19.7)
Data are presented as mean ± SDs, medians and ARDS 2 (3.3) 7 (11.5)
Underlying disease .600
interquartile ranges (IQRs), or proportions, as appropriate.
Chronic lung disease 12 (19.7) 13 (21.3)
Analyses were based on intention to treat and the χ2 test,
Neuromuscular disease 5 (8.2) 4 (6.6)
Fisher exact test, Student t test, or Wilcoxon rank sum test Chronic liver disease 3 (4.9) 6 (9.8)
was used to test for significant differences, as appropriate. Trauma 4 (6.6) 5 (8.2)
Multivariate linear regression was used to control for Neoplasm 17 (27.9) 21 (34.4)
confounding factors in patients' baseline characteristics. A None 20 (32.8) 12 (19.7)
P b .05 was considered statistically significant. Based on APACHE II score, 24.8 ± 7.3 25.4 ± 7.1 .607
the differences of weaning times in our pilot study, our mean ± SD
sample size had 80% power to detect a significant effect, Minimum PaO2/FIO2, 132.3 ± 67.6 112.4 ± 57.8 .074
assuming that the 2-sided type I error was 0.05 and the rate of during ICU stay,
the failure of discontinuation was 30%. mean ± SD
Respiratory failure 81 (44-138) 111 (56-167) .157
duration before
study entry (h) a
3. Results a
Data are presented as median (IQR).

3.1. Demographic and clinical characteristics

of patients
Table 2 shows the demographic and clinical characteris-
tics of all enrolled patients. There were no significant
differences between the 2 treatment groups in age,
underlying disease, or severity of illness upon ICU
admission based on Acute Physiology and Chronic Health
Evaluation II (APACHE II) score. There were 19 women in
the PBW group (31.1%) and 14 women in the UC group
(23.0%, P = .308). Patients in the PBW group were more
likely to be admitted from an in-patient floor (34 patients,
55.7% vs 29 patients, 47.5%), to be in a postoperative state
(6 patients, 9.8% vs 1 patient, 1.6%), and to have pneumonia
(25 patients, 41.0% vs 21 patients, 34.4%). Patients in the
UC group were more likely to have acute exacerbations of
chronic respiratory disease (10 patients, 16.4% vs 14
patients, 23.0%) and ARDS (2 patients, 3.3% vs 7 patients,
11.5%). Nevertheless, there were no significant differences
between the groups in routes of admission (P = .362) and
reasons for initiation of mechanical ventilation (P = .132).
Although the UC group had a longer median duration of
respiratory failure before study onset (81 hours, IQR 44-138
hours vs 111 hours, IQR 56-167 hours), this difference was
not significant (P = .157). There was a tendency for patients
of the PBW group to have higher minimum PaO2/FIO2 during
the ICU stay (132.3 ± 67.6 vs 112.4 ± 57.8; P = .074).
3.2. Effect of the weaning protocol
Intention-to-treat analyses indicated no significant differ-
ence between the PBW and UC groups in the number of
patients who successfully discontinued mechanical ventila-
tion (46 patients, 75.4% vs 47 patients, 77.0%; P = .832).
Univariate Cox analysis indicated that sex (hazard ratio
[HR], 0.583; 95% confidence interval [CI], 0.371-0.914; P =
.019), minimum PaO2/FIO2 during the ICU stay (HR, 1.008;
95% CI, 1.004-1.011; P b .001), and duration of respiratory
failure before study entry (HR, 0.995; 95% CI, 0.992-0.998;
Wearing protocol for patients from mechanical ventilation 553

Table 3 Factors related to successful weaning: univariate P = .069) (Table 5). There were no statistically significant
Cox model differences in the other outcomes, including duration of
Parameters HR 95% CI P hospitalization and frequency of complications (tracheos-
tomy, failure of discontinuation, and death) (Table 5).
Age 0.998 0.982-1.015 .842
Male 0.583 0.371-0.914 .019
Routes of admission .453
In-patient floor (reference) 4. Discussion
Emergency department 0.925 0.610-1.400 .711
Other ICU 2.297 0.550-9.957 .254
The present prospective, randomized trial of patients on
Reasons for initiating .063
mechanical ventilation mechanical ventilation clearly demonstrated that an easily
ARDS (reference) implemented weaning protocol administered by nurses was
Pulmonary edema 1.286 0.430-3.847 .653 safe and effectively reduced the weaning time relative to UC
Pneumonia 1.436 0.606-3.401 .411 by physicians. This protocol required no additional staff and
Sepsis 1.704 0.679-4.275 .256 minimal training of nurses. A physician's order was
Acute exacerbation of 1.031 0.400-2.656 .949 required only for extubation when a patient met objective
chronic respiratory extubation criteria.
disease The primary benefits of our weaning protocol is that nurses,
Postoperative state 4.188 1.386-12.652 .011 who are responsible for fewer patients than physicians, are able
Underlying disease .698
to respond more rapidly to changing patient status by making
Chronic lung disease
suitable adjustment of FIO2, PEEP, and inspiratory pressure,
(reference)
Neuromuscular disease 1.576 0.683-3.638 .286 thus allowing more rapid weaning. This is in agreement with
Chronic liver disease 1.299 0.512-3.294 .582 previous studies [4,5]. Rotello et al [9] reported that a nurse-
Trauma 1.984 0.856-4.599 .110 directed oxygen weaning protocol that used a single arterial
Neoplasm 1.229 0.670-2.252 .505 blood gas analysis and multiple pulse oximetry measurements
None 1.223 0.673-2.223 .509 was safe, reduced the need for arterial puncture, and decreased
APACHE II score 0.996 0.961-1.034 .850 the duration of oxygen weaning time to FIO2 of 50% or less.
Minimum PaO2/FIO2, during 1.008 1.004-1.011 b.001 This supports our hypothesis that the more rapid responses and
ICU stay more frequent monitoring provided by ICU nurses accelerate
Respiratory failure duration 0.995 0.992-0.998 .002 the weaning process.
before study entry
Our univariate analysis indicated a significantly shorter
weaning time in the PBW group than in the UC group (P =
P = .002) were significant predictors of unsuccessful .010). However, multivariate analysis using a linear regres-
weaning (Table 3). sion model indicated only a tendency for a shorter weaning
Multivariate Cox regression analysis indicated that male time in the PBW group (P = .069). The median duration of
sex (HR, 0.530; 95% CI, 0.335-0.840; P = .007) and respiratory failure, one of variables independently related to
minimum PaO2/FIO2 during ICU stay (HR, 1.008; 95% CI, weaning time in our multivariate linear regression model, was
1.005-1.012; P b .001) were significant independent pre- longer in the UC group than the PBW group (although not
dictors of unsuccessful weaning, but that the weaning significantly longer based on a t test). Thus, we believe that
protocol was not independently associated with successful the duration of respiratory failure was a confounding factor
weaning (Table 4). that modified our primary outcome, so that the weaning time
The median weaning time (primary outcome) was 47 was not significantly different in the PBW and UC groups by
hours (IQR, 24-186 hours) in the UC group and 25 hours multivariate linear regression. The lack of statistical signif-
(IQR, 5.75-134 hours) in the PBW group (P = .010) (Fig. 2). icance in the multivariate analysis may also have been caused
Multivariate analysis using a linear regression model that by our small sample size.
considered sex, age, routes of admission, reasons for Many previous studies that investigated the effectiveness
initiation of mechanical ventilation, underlying disease, of a protocol for weaning from mechanical ventilation used
APACHE II score, minimum PaO2/FIO2 during the ICU the overall duration of mechanical ventilation as the primary
stay, and duration of respiratory failure before study entry as
covariates indicated a tendency for a reduced weaning time in Table 4 Factors related to successful weaning: multivariate
the PBW group (P = .069). Patients assigned to the PBW Cox model
group also had a shorter median overall duration of Parameters HR 95% CI P
mechanical ventilation (139 hours, IQR 60.75-232.25 hours Male 0.530 0.335-0.840 .007
vs 151 hours, IQR 102-402 hours; P = .016) and a tendency Minimum PaO2/FIO2, during 1.008 1.005-1.012 b .001
for a shorter median length of stay in the ICU than the UC ICU stay
group (12 days, IQR 6-21 days vs 14 days, IQR 9-22 days;
554 J.H. Roh et al.

Fig. 2 Primary outcomes of the PBW and UC groups. A, Box-and-whisker plot of weaning time of patients who were successfully weaned
before ICU discharge. Horizontal line: median; box: 25th to 75th percentile; whiskers: 10% and 90% CI. Protocol-based weaning group (n =
46): median (IQR), 25 hours (5.75-134 hours); UC group (n = 47): median (IQR), 47 hours, 24-186 hours; P = .010. B, Kaplan-Meier curves of
the groups showing the probability of remaining on mechanical ventilation.

outcome [4-6,8]. However, our primary end point was
weaning time, defined as the time from enrollment to
successful discontinuation of mechanical ventilation
[4-6,8]. In previous studies that focused on finding patients
capable of breathing spontaneously, nurses or respiratory
therapists screened patients upon intubation and enrollment.
The present study is different in that nurses were given the
role of weaning the patients who had recovered from the
condition that caused respiratory failure. Although the
patients were recovering from these conditions, their
ventilators were operated at their physician's discretion, and
therefore, the weaning protocol should not have influenced
the resolution of patients' respiratory failure. Thus, we
believe that weaning time is more valid primary outcome
measure than overall duration of mechanical ventilation.
The weaning protocols used in previous studies were most
likely to be effective in surgical ICU patients. Blackwood et
al [12] found in a recent meta-analysis that only surgical
ICUs had significant reductions of total duration of
mechanical ventilation in the weaning protocol group,
based on subgroup analysis to assess the impact of ICU
type on outcome. This is another notable difference between
our study and other similar investigations. In particular, the
study of Marelich et al [6] was similar to our study in that
nonphysicians operated mechanical ventilators according to
a predefined protocol. Our subjects had more prolonged
respiratory failure (PBW group, 81 hours IQR 44-138 hours;
UC group, 111 hours, IQR 56-167 hours) than those of
Marelich et al (medical ICU intervention, 56.7 ± 103.1;
control, 75.6 ± 131.1; surgical ICU intervention, 51.0 ±
111.0; control, 37.0 ± 47.6) and consisted of only medical
ICU patients who presumably have more comorbidities than
patients in surgical ICUs (Marelich et al had 170 medical
ICU patients and 165 surgical ICU patients).
The present study had several potential limitations.
Although this study was prospective, randomized, and
controlled, blinding was not possible. Thus, nurses might
have been motivated to wean patients assigned to the PBW
group; however, this effect may have been countered by
similarly motivated physicians in the UC group. Another

Table 5 Secondary outcomes of the PBW and UC groups

Outcome PBW UC P
a
Duration of MV (h) 139 (60.75-232.25) 151 (102-402) .016
ICU length of stay (d) a 12 (6-21) 14 (9-22) .069
Hospital length of stay (d) a 39 (22-64) 41 (27.25-81.5) .576
Discontinuation failure (%) 15 (24.6) 14 (23.0) .832
Tracheostomy (%) 5 (8.2) 3 (4.9) .464
Hospital deaths (%) 9 (14.8) 11 (18.0) .625
MV indicates mechanical ventilation.
a
Data are presented as median (IQR) and collected among patients who discontinued mechanical ventilation before ICU discharge (PBW group, n = 46;
UC group, n = 47).
Wearing protocol for patients from mechanical ventilation
limitation is that because physicians and nurses were aware
they were being observed, they might have been more
diligent in managing their patients, an example of the
Hawthorne effect [13].
Clearly, it is very important to establish the safety of a
protocol for weaning from respiratory ventilation. However,
it is difficult to study complications related to a weaning
protocol for several reasons. Minor complications, such as a
transient decline of SO2 or tachypnea, might have been
caused by nurses' violating the terms of the protocol, but
these may not have been noted because they were resolved
by the supervision of senior nurses. Major complications,
which might have been caused by intrinsic problems with the
protocol, overlap with general complications related to
mechanical ventilation itself. This is the reason why we
classified the presence of these complications as secondary
outcome measures. We implemented 2 safety measures to
prevent complications. First, as mentioned above, senior
nurses supervised the nurses who were actually implement-
ing the protocol. Second, a physician could stop nurses from
operating the mechanical ventilator if a physician thought the
protocol was inappropriate based on the patient's condition.
The AMC provides better care than what is available
elsewhere in Korea and in most developing Asian countries.
In particular, the AMC has respiratory therapists, unlike most
hospitals in Korea. When we started to design this study, we
were not certain that weaning protocol would work well in
Korea because most ICUs in Korea did not have respiratory
therapists. Previous studies on weaning protocol involved
respiratory therapists in implementing weaning protocol or
did not specify if respiratory therapists were involved. For
this reason, we tried to make the PBW group simulate other
ICUs in our country, which was in lack of human resources.
In the PBW group, physicians and respiratory therapists were
not allowed to operate the mechanical ventilators and make
decisions about weaning process, except under serious
circumstances. Although other ICUs lack other resources,
such as nurses, equipments, and so on, we think that
physicians and respiratory therapists are most important and
expensive human resources for these ICUs to wean patients
from mechanical ventilation.
Physicians in developing countries may hesitate to adopt
weaning protocol for their ventilated patients because of the
lack of respiratory therapists, conflicting results of previous
studies of weaning protocol, and relatively weak evidence
for medical ICU patients. Our results clearly indicate that
weaning protocol administered by nurses can be effective in
ICUs that have limited resources.
5. Conclusions
In summary, our nurse-directed protocol for weaning
from mechanical ventilation does not require a respiratory
555
therapist and was associated with shorter weaning time and
overall duration of ventilation than traditional physician-
directed weaning. Implementation of nurse-directed weaning
protocol may contribute to better management of ICU
patients in Korea and in developing regions of Asia, which
have few respiratory therapists and physicians trained in
critical care medicine.
Acknowledgments
We are grateful to all the physicians and nurses of the
Medical Intensive Care Unit of Asan Medical Center, Seoul,
Korea, without whose help and dedication this work could
not have been possible. This work was not funded by any
external source.
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