Ferrer, 2003

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Noninvasive Ventilation improves outcome in patients who are difficult to wean from mechanical ventilation compared to conventional weaning methods

Non invasive ventilation reduces death, serious complication rate and length of ICU stay in patients who are difficult to wean compared to conventional weaning methods

Level of Evidence: 1⁺(RCT with a low risk of bias)

Citation/s: Ferrer M, et al. Noninvasive Ventilation during Persistent Weaning Failure: A Randomized Controlled Trial. Am J Respiratory Crit Care Medicine Vol 168 pp 70-76 2003.

Lead author's name and email: Miquel Ferrer, miferrer@clinic.ub.es

Three-part Clinical Question: Is the use of noninvasive ventilation more effective in weaning patients who have persistent weaning failure compared to conventional weaning approaches?

Search Terms: 1. Weaning failure (155); 2. Noninvasive ventilation (396) 1+2=(5)

The Study:Non-blinded randomized controlled trial with intention-to-treat.

The Study Patients: Intubated patients who were ready to be weaned as defined by specific criteria, but had failed a spontaneous breathing trial on 3 consecutive days. 80% had a chronic pulmonary disorder.

Control group (N = 22; 22 analyzed): Conventional Weaning: Patients were reconnected to the ventilator, and were subject to once-daily weaning attempts

Experimental group (N = 21; 21 analyzed): NIV Group: Patients were extubated and were given NIV (BIPAP) for at least 24 hours, and thereafter gradually withdrawn until spontaneous breathing tolerated

The Evidence:

Outcome	Time to Outcome	CER	EER	RRR	ARR	NNT
Serious Complication Rate	90 days	0.72	0.24	67%	0.480	2
Serious Complication Rate	95% Confidence Intervals:			30% to 100%	0.218 to 0.742	1 to 5
Death	90 Days	0.591	0.286	52%	0.305	3
Death	95% Confidence Intervals:			4% to 99%	0.023 to 0.587	2 to 44
Reintubation Rate	90 Days	0.273	0.143	48%	0.130	NS
Reintubation Rate	95% Confidence Intervals:			NS	NS	NS

Non-Event Outcomes	Control group	Experimental group	P-value
Length Of Invasive Ventilation (Days)	20.1+/- 13.1 days	9.5+/- 8.3 days	0.003
Length Of ICU Stay	25+/- 12.5 days	14.1+/- 9.2 days	0.002
Hospital Stay	40.8+/- 21.4 days	27.8+/- 14.6 days	0.026

EBM Questions:

1. Do the methods allow accurate testing of the hypothesis: Yes. Although the numbers in each group was relatively small (n= 21/22) due to a high number of patients excluded initially.

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

3. Are conclusions valid in light of the results? Yes
Did results get omitted and why? Yes

4. The planned interim analysis after inclusion of 50% of the estimated patients revealed a significant reduction of the duration of invasive ventilation in the NIV group, the study was therefore stopped early at this stage.

5. Did they suggest further areas of research? No

6. Did they make any recommendations based on the results and were they appropriate? NIV should be used in patients with weaning failure in ICU in order to reduce mortality and complication rate and length of ICU stay. These recommendations are appropriate.

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 on this alone? B

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

11. Should I change my practice because of these results? Yes. I will be considering the use of NIV in more patients who have difficulty weaning from the ventilator

Appraised by: Pam Doherty SpR Anaesthesia, Western Infirmary, Glasgow; Tuesday, July 05, 2005
Email: pamdoherty@doctors.org.uk

Edited & Reviewed by KR & CC.

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Doherty P. 2005. Ferrer M, et al. Noninvasive Ventilation during Persistent Weaning Failure: A Randomized Controlled Trial. Am J Respiratory Crit Care Medicine Vol 168 pp 70-76 2003.

Kill or Update By: July 2008

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