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Noninvasive ventilation for respiratory failure post extubation is harmful

Citation/s: Esteban A, et al. Non-invasive Positive Pressure Ventilation for Respiratory Failure after extubation. New Engl J Med 2004;350:2452-69

Lead author's name and fax: Esteban et al: aesteban@ucigetafe.com

Three-part Clinical Question: Does the use of NIV in patients with respiratory failure post extubation decrease mortality and reduce the need for reintubation compared with standard medical therapy?
 

Search Terms: Noninvasive ventilation (359) Ventilator Weaning (1553) Extubation (3243) 1+ 2 + 3 (10)

The Study: Single-blinded randomised controlled trial with intention-to-treat.
 

The Study Patients: All adult patients who had been successfully extubated after a completion of a trial of spontaneous breathing but who subsequently developed respiratory failure in the 48hrs following extubation.
 

Control group (N = 107; 107 analysed): Given routine medical care post extubation i.e supplemental oxygen, physiotherapy; bronchodilators
 

Experimental group (N = 114; 114 analysed): Given NIV through full facial mask to achieve a tidal volume of >5ml/Kg and a respiratory rate

The Evidence:

Comments:
The interval between the development of respiratory failure and reintubation was significantly longer in the noninvasive group (median 12 hours; interquartile range 2 hours and 10mins to 28 hours) than in standard therapy group (median 2 hours 30 mins; interquartile range 45 mins to 16 hours 30 mins)

EBM questions:

1.      Do the methods allow accurate testing of the hypothesis? YES. Although non-tolerance of NIV seems to have been somewhat overlooked. There were 5 patients who did not tolerate the NIV but only 2 of these were reintubated. It is unclear whether these other 3 were excluded or not. Also NIV success depends somewhat on user experience. No indication of reason of respiratory failure post extubation.

2.      Do the stastistical tests correctly test the results to allow differentiation of stastistically significant results? YES

3.      Are the conclusions valid in light of the results? YES

4.      Did results get omitted and why? YES. All patients who immediately developed respiratory failure were omitted without any trial of NIV or conventional treatment. Stopped at interim analysis due to observed mortality rate in NIV group being higher than in standard therapy with p<0.05.

5.      Did they suggest areas of further research? NO. However a similar study in patients with COPD may show different results and may be worthwhile as in the patients with COPD (n=23) the rate of reintubation was lower in those in NIV group but sample too small to be significant.

6.      Did they make any recommendations based on the results and were they appropriate? NO

7.      Is this study relevant to my clinical practice? YES

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

9.      What grade of recommendation can I make from this result alone? B

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

11.  Should I audit my current practice because of these results? YES. There are some patients whom we may consider trying on NIV following a failed extubation, and following the results of this trial we may be doing them harm.

Appraised by: Pam Doherty. SpR Western Infirmary, Glasgow.; Wednesday, April 27, 2005

Email: pamdoherty@doctors.org.uk

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Doherty P. 2005. Esteban A, et al. Non-invasive Positive Pressure Ventilation for Respiratory Failure after extubation. New Engl J Med 2004;350:2452-69.

Reviewed & Edited by CC & KR

Kill or Update By: April 2008

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