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ORIGINAL ARTICLE
Protocol-directed versus physician-directed weaning from
noninvasive ventilation: The impact in chronic obstructive
pulmonary disease patients
Jun Duan, Xiaokui Tang, Shicong Huang, Jinwei Jia, and Shuliang Guo, MD, Chongqing, China
BACKGROUND: Noninvasive ventilation (NIV), a technique widely used in intensive care units (ICUs), eliminates the need for many patients in
respiratory failure to undergo intubation. However, few articles have described how to wean patients from NIV. Herein, we put
forward a protocol to be performed by respiratory therapists to wean patients from NIV.
METHODS:
A prospective, randomized, controlled trial was performed in a respiratory ICU of a teaching hospital. Respiratory therapists
screened patients daily. In the protocol-directed weaning group, the weaning attempt was initiated according to the protocol. In the
physician-directed weaning group, the weaning attempt was initiated according to physicians’ orders.
RESULTS:
At randomization, patients in the two groups had similar clinical characteristics. A total of 73 patients were successfully weaned from
NIV (37 in the protocol-directed group and 36 in the physician-directed group). The preponderance of them (64%) was chronic
obstructive pulmonary disease patients. Compared with physician-directed weaning, protocol-directed weaning reduced the duration of
NIV (4.4 ⫾ 2.5 days vs. 2.6 ⫾ 1.5 days, respectively, p ⬍ 0.001) and the duration of the ICU stay (8.1 ⫾ 5.5 days vs. 5.8 ⫾ 2.7 days,
respectively, p ⫽ 0.02). In the protocol-directed group, the successful weaning rate was 57%, 27%, 13%, 0%, and 3% on the 1st, 2nd, 3rd, 4th,
and 5th days after randomization, respectively.
CONCLUSIONS: Protocol-directed weaning reduces the duration of NIV and the duration of the ICU stay. (J Trauma. 2012;72: 1271–1275.
Copyright © 2012 by Lippincott Williams & Wilkins)
LEVEL OF
EVIDENCE:
II.
KEY WORDS:
Noninvasive ventilation; weaning; protocol.
N
oninvasive ventilation (NIV), as defined by Hill,1 is a
technique that augments alveolar ventilation without using
an artificial airway. In recent years, NIV has been increasingly
used to treat acute respiratory failure.2,3 It reduces respiratory
muscle load and the work associated with breathing, improves
gas exchange, and relieves patients’ symptoms. Compared with
invasive ventilation, NIV reduces the incidences of complications and ventilator-associated pneumonia.4,5
NIV has been successfully used in the patients with
acute exacerbation of chronic obstructive pulmonary disease
(COPD). It involves a lower risk of intubation, lower risk of
mortality, lower risk of complications, and shorter length of
hospital stay.6 – 8 It also significantly improves PaO2 and
reduces PaCO2 and the respiratory rate.9 In patients with acute
asthmatic attack, NIV improves lung function test results and
reduces hospitalization.10 Among immunosuppressive patients, it reduces the intubation rate, the length of stay in the
intensive care unit (ICU), and the risk of mortality.11,12
Submitted: July 4, 2011, Revised: January 4, 2012, Accepted: January 4, 2012.
From the Department of Respiratory Medicine, First Affiliated Hospital, Chongqing Medical University, Chongqing, People’s Republic of China.
Address for reprints: Shuliang Guo, MD, Department of Respiratory Medicine,
First Affiliated Hospital, Chongqing Medical University, Youyi Road 1,
Yuzhong District, Chongqing 400016, People’s Republic of China; email:
guosl999@163.com/guosl999@sina.com.
DOI: 10.1097/TA.0b013e318249a0d5
Among postoperative patients, it also reduces the need for
reintubation caused by respiratory failure.13
Mechanical ventilation has considerable costs14; therefore,
decreasing its duration is important for health care professionals.
Many protocols have been used to manage patients on mechanical ventilation and to decrease the duration of the ventilation.15
Although NIV has been widely used with patients in respiratory
failure, few articles have reported how to wean patients from
NIV. In this article, we put forward a protocol to be performed
by respiratory therapists to wean patients from NIV.
METHODS
Patients
This study was performed in a respiratory ICU of a
teaching hospital from July 2010 to May 2011. It was approved
by the hospital’s Ethics Committee, and written informed consent was obtained in all cases. A total of 181 patients received
NIV for more than 24 hours. However, 101 patients were
excluded for various reasons (Fig. 1). Thus, 80 patients were
enrolled in the study. However, seven patients were excluded
from the analysis: one for pneumothorax, one for transfer to
another hospital, two for death, and three for intubation (Fig. 1).
The inclusion criteria were as follows: (1) NIV ⬎24
hours, (2) age ⱖ18 years, and (3) ventilator mode bilevel
positive airway pressure (BiPAP Vision, Respironic Inc.,
Murrysville, PA). The exclusion criteria were as follows: (1)
J Trauma
Volume 72, Number 5
1271
J Trauma
Volume 72, Number 5
Duan et al.
Figure 1. Trial profile. CPAP, continuous positive airway pressure.
severe heart failure with cardiac index ⱕ2 L/min/m2, (2)
severe hepatic failure with bilirubin ⱖ34.2 ␮mol/L, (3) severe renal failure with creatinine ⱖ220 ␮mol/L, (4) use of
NIV to wean patients from invasive ventilation, and (5)
rejection of intubation instead of NIV.
The primary outcome was the duration of NIV from
admission to discharge. The secondary outcomes were the
duration of NIV after randomization, the duration of ICU
stay, and the duration of hospital stay. The patient was
considered successfully weaned when he or she no longer
required NIV support for the duration of the hospital stay.
Principle of General Management in NIV
Patients
The patients who needed NIV support were decided by
the physicians according to the general management principle of
our hospital (see the Appendix A). The patients who received
bilevel positive airway pressure support were titrated as follows:
the arterial blood gases (ABG) were tested routinely before NIV
and NIV of 2 hours later, 8 hours later, and 24 hours later. After
24 hours of NIV, the ABG were repeated every morning. If the
physician suspected the patient’s condition deteriorated, they
would order a temporary ABG. The inspiratory positive airway
pressure and respiratory rate were titrated according to the tidal
volume, minute ventilation, respiratory rate, ABG, and the
patient clinical symptoms. The expiratory positive airway pressure was kept at 4 cm H2O to 8 cm H2O, and the FIO2 was
1272
titrated according to the bedside oximeter and the ABG to
maintain SpO2 ⬎90% and PaO2 ⬎60 mm Hg. If the patient’s
clinical condition did not improve (see the Appendix B), he or
she was intubated for higher support. All the patients received
common treatment such as anti-inflammatory, diuresis, expectorant, nebulization inhalation, and so on when necessary.
Criteria for the Daily Screen
Every morning, the ABG was obtained routinely, and
then a daily screen was performed by respiratory therapists to
determine whether the patients satisfied all the following
conditions: (1) pH ⱖ7.30, FIO2 ⱕ0.5, PaO2 ⬎60 mm Hg,
PaO2/FIO2 ⬎150, and SaO2 ⱖ92%; (2) respiratory rate 8
breaths/min to 30 breaths/min; (3) systolic blood pressure 90
mm Hg to 180 mm Hg without vasopressor; (4) temperature
36 °C to 38°C; (5) heart rate 50 bpm to 120 bpm; (6) Glasgow
Coma Scale ⱖ13. If patients passed the daily screen, they
were randomly allocated to either a protocol-directed weaning group or a physician-directed weaning group.
Protocol-Directed Weaning Group
In the protocol-directed weaning group, weaning from
NIV was performed by respiratory therapists. When patients
were allocated to this group, the weaning attempt was initiated. Respiratory therapists directly disconnected the patients
from NIV and oxygenated them with a nasal cannula. Oxygen
flow was limited to no more than 5 L/min. According to the
© 2012 Lippincott Williams & Wilkins
J Trauma
Volume 72, Number 5
Duan et al.
patients’ tolerance, the oxygenation by a nasal cannula was
continued until the patient was discharged. If the patients
seemed to fail the weaning, the ABG was obtained to help
judgment. The patients were reconnected to NIV with the
previous parameters if they could not sustain spontaneous
breathing and experienced one of the following: (1) respiratory rate ⱖ30 bpm for more than 5 minutes; (2) SpO2 ⱕ90%
with oxygen flow ⱖ5 L/min for more than 5 minutes; (3) pH
ⱕ7.3; (4) an increase of more than 10 mm Hg in PaCO2; (5)
heart rate ⱖ120 bpm or ⱕ50 bpm; (6) systolic blood pressure
ⱖ180 mm Hg or ⱕ90 mm Hg; (7) diminished consciousness,
diaphoresis, clinical signs of respiratory muscle fatigue, labored breathing, or any combination of these. Then 24 hours
later, if patients once again satisfied the daily screen, they
were again disconnected from NIV.
Physician-Directed Weaning Group
Patients who were allocated to the physician-directed
weaning group were also examined daily by respiratory
therapists. However, the patients in this group were weaned
from NIV only on physicians’ orders (five resident physicians
with at least 3-year clinical training, two attending physicians, and one associate chief physician). Physicians themselves, nurses, or respiratory therapists (who were not taking
part in this study) would take an action according to the
physicians’ order. If patients’ condition deteriorated during
the weaning attempt, the nurses or respiratory therapists (who
were not taking part in this study) would inform the physician
immediately and took action as the physician’s order.
TABLE 1.
Baseline Characteristics of NIV Patients
Age, yr
Gender, male/female
Cause of NIV, N
Exacerbation of COPD
Pneumonia
Asthma
other
APACHE II score at admission
to RICU
Data at randomization
APACHE II score
IPAP (cm H2O)
EPAP (cm H2O)
Respiratory rate (breaths/min)
Heart rate (beats/min)
Systolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
PH
PaCO2
PaO2
FIO2
PaO2/FIO2
Duration of NIV (d)
ProtocolDirected
Group
(n ⴝ 37)
PhysicianDirected
Group
(n ⴝ 36)
p
71.3 ⫾ 12.3
27/10
71.8 ⫾ 13.5
29/7
0.86
—
25
7
3
2
19.0 ⫾ 4.5
22
11
2
1
20.5 ⫾ 5.2
—
—
—
—
0.20
15.8 ⫾ 3.2
15.7 ⫾ 3.5
4.8 ⫾ 1.2
22.4 ⫾ 3.5
94.9 ⫾ 16.2
126.8 ⫾ 18.3
75.4 ⫾ 9.1
7.44 ⫾ 0.06
48.4 ⫾ 13.1
89.9 ⫾ 23.1
0.41 ⫾ 0.08
226.3 ⫾ 63.8
1.8 ⫾ 1.1
14.3 ⫾ 3.4
16.4 ⫾ 2.3
4.6 ⫾ 1.0
22.4 ⫾ 2.6
92.9 ⫾ 13.9
124.4 ⫾ 16.3
73.1 ⫾ 14.1
7.43 ⫾ 0.04
48.0 ⫾ 13.2
97.9 ⫾ 28.8
0.40 ⫾ 0.04
250.2 ⫾ 75.1
1.7 ⫾ 0.5
0.06
0.29
0.44
0.96
0.56
0.56
0.42
0.63
0.89
0.20
0.51
0.15
0.69
NIV, noninvasive mechanical ventilation; APACHE II, Acute Physiology And
Chronic Health Evaluation II score; RICU, respiratory intensive care unit; IPAP,
inspiratory positive airway pressure; EPAP, expiratory positive airway pressure.
Statistical Analysis
Data are reported as the mean ⫾ standard deviation.
Baseline characteristics and outcomes were analyzed with
unpaired sample t tests. The probability of patients remaining
on NIV and in the ICU was analyzed using Kaplan-Meier
analyses (log-rank test).
RESULTS
A total of 37 patients (including 25 COPD patients)
were successfully weaned from NIV in the protocol-directed
weaning group and 36 (including 22 COPD patients) in the
physician-directed weaning group. The baseline characteristics of the patients in two groups were similar (Table 1).
Compared with the physician-directed weaning, the
protocol-directed weaning reduced the duration of NIV by
1.8 days (4.4 ⫾ 2.5 days vs. 2.6 ⫾ 1.5 days, respectively, p ⬍
0.001) and the duration of the ICU stay by 2.3 days (8.1 ⫾ 5.5
days vs. 5.8 ⫾ 2.7 days, respectively, p ⫽ 0.02). After
randomization, patients in the protocol-directed group had a
shorter duration of NIV (0.8 ⫾ 1.1 days vs. 2.7 ⫾ 2.5 days for
the physician-directed group, p ⬍ 0.001; Table 2).
The successful weaning outcomes for the protocoldirected group are summarized in Table 3. After randomization, the successful weaning rate for this group was 57%,
27%, 13%, 0%, and 3% on the 1st, 2nd, 3rd, 4th, and 5th
days, respectively.
© 2012 Lippincott Williams & Wilkins
TABLE 2.
Study Outcomes
Duration of ICU stay (d)
Duration of hospital stay (d)
Duration of NIV (d)
Duration of NIV after
randomization (d)
ProtocolDirected
Group
(n ⴝ 37)
PhysicianDirected
Group
(n ⴝ 36)
p
5.8 ⫾ 2.7
17.4 ⫾ 13.0
2.6 ⫾ 1.5
0.8 ⫾ 1.1
8.1 ⫾ 5.5
19.1 ⫾ 14.6
4.4 ⫾ 2.5
2.7 ⫾ 2.5
0.02*
0.60
⬍0.001†
⬍0.001†
ICU, intensive care unit; NIV, noninvasive ventilation.
* p ⬍ 0.05 for protocol-directed weaning group vs. physician-directed weaning
group.
†
p ⬍ 0.001 for protocol-directed weaning group vs. physician-directed weaning
group.
DISCUSSION
Many studies have demonstrated that a weaning protocol reduces the duration of invasive mechanical ventilation,
the duration of ICU and hospital stays, the risk of ventilatorassociated pneumonia, and the risk of mortality.16 –18 But few
articles have reported on weaning protocols used with patients on NIV. Here, we put forward a protocol to be performed by respiratory therapists to wean patients from NIV.
Compared with physician-directed weaning, this protocol
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J Trauma
Volume 72, Number 5
Duan et al.
TABLE 3. Successful Weaning Rate and Reasons for
Weaning Failure in the Protocol-Directed Weaning Group
After Randomization
1st
Day
2nd
Day
3rd
Day
4th
Day
5th
Day
Successful weaning
21 (57%) 10 (27%) 5 (13%) 0 (0%) 1 (3%)
number (%)
Weaning failure reasons, n
SpO 2 ⱕ90%
12
3
1
1
—
HR ⱖ120 (beats/min)
4
—
—
—
—
RR ⱖ30 (breaths/min)
3
—
—
—
—
SBP ⱖ180 mm Hg
1
1
—
—
—
⌬PaCO 2 ⱖ10 mm Hg
—
1
—
—
—
Other
1
1
—
—
—
HR, heart rate; RR, respiratory rate; SBP, systolic blood pressure.
⌬PaCO 2 ⫽ Increase in PaCO 2 without NIV support.
reduces the duration of NIV by 1.8 days and the length of stay
in the ICU by 2.3 days (Table 2).
Damas et al.19 used progressive periods of withdrawal
from NIV. On day 1, each 3-hour period during the day
involved 2 hours with and 1 hour without NIV. At night,
patients were under continuous NIV. On day 2, each 3-hour
period during the day involved 1 hour with and 2 hours
without NIV; again, at night patients were under continuous
NIV. On day 3, patients received no NIV during the day and
continuous NIV during the night. However, Hall and Wood20
suggested that a gradual withdrawal from mechanical ventilation is probably unnecessary for the majority of patients. In
our study, patients were screened daily. If patients passed the
daily screen, respiratory therapists performed once-daily
weaning attempts. This strategy revealed the potential patients who did not need NIV support. In the protocol-directed
weaning group, 57% of patients were weaned from NIV on
the first day and 84% on the second day.
The probability of remaining on NIV and in the ICU
was much higher for patients in the physician-directed weaning group (Figs. 2 and 3). Identifying when the patients in this
group are ready to go off NIV depends on the judgment and
experience of the physician. Different physicians have different experiences, skills, and weaning philosophies. It is arbitrary to decide which patients to remove from ventilation
based on physician experience. Without an objective evaluation, some patients may artificially prolong the duration of
NIV. An early study reported that the clinical decision to
wean from mechanical ventilation was often based on physician experience, which ultimately increased the cost and
duration of mechanical ventilation.21 Many studies demonstrated that the weaning protocol drove by respiratory therapists decreased the duration of mechanical ventilation.17,18
Similar outcomes were in our study (Table 2).
Mechanical ventilation often saves lives, but it is expensive. The costs, which mainly related to mechanical ventilation,
for a patient in ICU is approximately four times greater than a
patient who is not.22 Health care professionals today continually
struggle to reduce the duration of mechanical ventilation. Thus,
we have put forward a weaning protocol that decreases the
duration of NIV and the length of stay in the ICU (Table 2).
1274
Figure 2. Kaplan-Meier curves for patients remaining on
NIV. The probability of successful weaning was significantly
higher for patients in the protocol-directed weaning group
(solid lines) than in the physician-directed weaning group
(dashed lines; log-rank test, p ⱕ 0.001).
Figure 3. Kaplan-Meier curves for patients remaining in the
ICU. The probability of remaining in the ICU was significantly higher for patients in the physician-directed weaning
group (dashed lines) than in the protocol-directed weaning
group (solid lines; log-rank test, p ⫽ 0.021).
The reasons for weaning failure in this study were
increased heart rate, increased respiratory rate, increased
systolic blood pressure, and hypoxemia (the most common
reason; Table 3). Respiratory therapists and nurses closely
monitored the patients at bedside. If the weaning attempt
failed, the patients were immediately reconnected to NIV for
their own safety. Then 24 hours latter, the patients in the
protocol-directed weaning group were reevaluated. If they
satisfied the criteria, another weaning attempt was made until
the patients were permanently free of the ventilator.
© 2012 Lippincott Williams & Wilkins
J Trauma
Volume 72, Number 5
Our study has several limitations. (1) The sample size
was small. (2) The physician-directed weaning occurred just
according to the physicians’ experience. Different physicians
have different experience. An experienced physician may
wean a patient from NIV faster than a less experienced
physician. (3) Furthermore, it is not enough to demonstrate a
reduced duration of hospital stay, though we have demonstrated a reduced duration of NIV and ICU length of stay by
protocol-directed weaning. Thus, a study should be performed with a larger sample to demonstrate the efficiency of
protocol-directed weaning.
In conclusion, protocol-directed weaning performed by
respiratory therapists reduces the duration of NIV and the
duration of the ICU stay.
DISCLOSURE
The authors declare no conflicts of interest.
APPENDIX A: INDICATIONS AND
CONTRAINDICATIONS OF NIV
Indications for NIV
1.
2.
3.
4.
5.
6.
The patient is conscious and can response to our question
Respiratory rate ⬎30 breaths/min
pH ⬎7.2
PaO2 ⬍60 mm Hg at room air or PaO2/FIO2 ⬍150
Heart rate ⬎120 beats/min
These indications exclude the patients who refuse to
intubation and receive the NIV as a lifesaving support.
Contraindications for NIV
1.
2.
3.
4.
5.
6.
7.
8.
Facial or cranial trauma or surgery
Facial abnormalities
Recent gastric or esophageal surgery
Active upper gastrointestinal bleeding
High risk of aspiration
Unable to clear sputum
Hemodynamic instability
Lack of co-operation.
APPENDIX B: INDICATIONS FOR INTUBATION
INSTEAD OF NIV
The practitioners closely monitored the NIV patients,
especially at the beginning 2 hours of NIV. If the patients’
clinical condition hasn’t improved even deteriorated during
the initial 2 hours of NIV, the intubation was performed. At
any time after initial 2 hours of NIV, the intubation was
performed if the patients’ condition deteriorated.
No Improvement or Deterioration
1.
2.
3.
4.
5.
6.
A reduced level of consciousness
Respiratory rate ⬎35 breaths/min
pH ⬍7.2
PaO2/FIO2 ⬍150
Heart rate ⬎140 beats/min
Hemodynamic instability and need vasopressor drug.
© 2012 Lippincott Williams & Wilkins
Duan et al.
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