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Effect of prone positioning on the survival of patients with acute respiratory failure

 

 

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:

 

  1. Do the methods allow the adequate testing of the hypothesis? Yes

  2. Do the statistical tests correctly test the results to allow differentiation of statistically significant result? Yes

  3. Are conclusions valid in light of results? Yes

  4. Did results get omitted, and why? No

  5. Did they suggest areas of further research? Yes, Prone in severe ARDS

  6. 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

  7. Is this study relevant to my clinical practice? Yes, similar group of patients with similar severity of illness.

  8. What level of evidence does this study represent? 1++

  9. What grade of recommendation can I make on this result alone? A

  10. What grade of recommendation can I make when this study is considered along with other available evidence? A

  11. Should I change my practice because of these results? Yes

  12. 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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