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Effect of prone
positioning on the survival of patients with acute respiratory failure
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Prone
positioning in ALI and ARDS improves oxygenation but not mortality beyond 10
days in a large randomised controlled study.
Level of Evidence: 1++ |
Citation/s:
Gattinoni L. Tognoni G. Pesenti A. Taccone P. Mascheroni D. Labarta V. Malacrida
R. Di Giulio P. Fumagalli R. Pelosi P. Brazzi L. Latini R. Prone-Supine Study
Group. Effect of prone positioning on the survival of patients with acute
respiratory failure. New England Journal of Medicine 2001;
345(8):568-73.
Lead author's name and
fax: Gattinoni
L
Clinical Question:
1. Which patients- All
comers with ALI and ARDS
2. Therapy- Prone
positioning
3. Outcome measures-
Mortality and oxygenation
Search Terms:
ARDS, Positional manoeuvres, prone positioning
The Study:
Single-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients:
ALI and ARDS according to American-European Consensus definitions. Mechanical
ventilation. Age > 16 years. 28 ICU in Italy and 2 in Switzerland.
Control group
N = 152; 152 analysed:
Routine ventilatory management according to American-European COnsensus
conference on mechanical ventilation guidelines
Experimental group
N = 152; 152 analysed:
Patients managed in the prone position for at least 6 hours per day for 10 days
if PaO2 / FiO2 ratio <200mmHg with PEEP > 5cmH2O or PaO2 / FiO2 ratio of <
300mmHg with PEEP > 10cmH2O. Routine ventilatory treatment according to American
European Consensus conference on mechanical ventilation guidelines.
The Evidence:
|
Outcome |
Time
to Outcome |
CER |
EER |
RRR
(95% CI) |
ARR
(95% CI) |
NNT
(95% CI) |
|
Death |
10
days |
0.250 |
0.211 |
16%
(-22% to 53%) |
0.039
(-0.056 to 0.134) |
26
(NNT = 7 to INF; NNH = 18 to INF) |
|
Death
|
ICU |
0.480 |
0.507 |
-6%
(-29% to 18%) |
-0.027 (-0.14 to 0.09) |
-37
(NNT = 12 to INF; NNH = 7 to INF) |
|
Death
|
6
months |
0.586 |
0.625 |
-7%
(-25% to 12%) |
-0.039 (-0.15 to 0.07) |
-26
(NNT = 14 to INF; NNH = 7 to INF) |
|
Oxygenation |
10
days |
Result- PaO2 / FiO2 ratio 44.6 in controls and 63 in treatment group
(p=0.02) |
|
Non-pulmonary OSF |
10
days |
Result- OSF 2.8 in prone group and 2.7 in controls (p=0.83) |
Abbreviations- CER-
Control event rate; EER- experimental event rate, RRR- relative risk ratio; ARR-
absolute risk ratio; NNT- number needed to treat; CI- confidence interval.
EBM Comments:
-
Do the methods allow the
adequate testing of the hypothesis? Yes
-
Do the statistical tests
correctly test the results to allow differentiation of statistically
significant result? Yes
-
Are conclusions valid in
light of results? Yes
-
Did results get omitted,
and why? No
-
Did they suggest areas
of further research? Yes, Prone in severe ARDS
-
Did they make
recommendations based on results and were they appropriate? Yes, that proning
should not be used routinely in the management of ARDS but may be consider
useful in severe hypoxaemia
-
Is this study relevant
to my clinical practice? Yes, similar group of patients with similar severity
of illness.
-
What
level of evidence does this study
represent? 1++
-
What
grade of recommendation can I
make on this result alone? A
-
What
grade of recommendation can I
make when this study is considered along with other available evidence? A
-
Should I change my
practice because of these results? Yes
-
Should I audit my
current practice because of these results? Yes
Conclusions:
A well designed and executed randomised controlled study or prone positioning in
ALI and ARDS which demonstrates no benefit in mortality associated with prone
positioning. The improvement in oxygenation associated with this manoeuvre may
be a useful temporising effect in the critically hypoxic ARDS patient. A similar
effect can be obtained in ARDS with inhaled NO therapy.
Appraised by:
Brian H Cuthbertson, ICU,
Aberdeen Royal Infirmary, Aberdeen,
Email:
b.h.cuthbertson@abdn.ac.uk
Date of appraisal-
February, 2004. Kill or Update By: Feb 2006
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