Respiratory failure & ventilation
Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial
Primary resultResult — go to the resultRelative risk 0.43 95% CI 0.31–0.60Authors' conclusion
Among critically ill adults with obesity undergoing extubation, the use of NIV was effective to reduce treatment-failure within 3 days.
Study context
- Population
- Critically ill patients with obesity undergoing extubation, 39 ICUs in France1,650 screened
- Participants
- 981 patients
- Comparison
- Non-invasive ventilation (NIV) vs oxygen therapy after extubation
- NIVn = 490
- Oxygen therapyn = 491reference
- Primary endpoint
- Treatment failure: composite of reintubation for mechanical ventilation, switch to the other study treatment, or premature discontinuation of study treatment
- Follow-up
- Within 3 days after extubation
Methodological detailsmulticentre, parallel group, pragmatic, unblinded, nested second randomisation (HFNO vs standard oxygen), statistician masked, Enrolment Oct 2, 2019, to July 17, 2021
- Multicentre
- Parallel group
- Pragmatic
- Unblinded
- Nested second randomisation (HFNO vs standard oxygen)
- Statistician masked
- Enrolment Oct 2, 2019, to July 17, 2021
Primary result
As reported in the abstract
Relative risk
0.43
95% CI 0.31–0.60
P < 0.0001
Events by treatment group
NIV vs Oxygen therapy
RR 0.43 (95% CI 0.31–0.60); P < 0.0001
Further findings
Reintubation (ITT) · within 3 days after extubation · intention-to-treat analysis
P = 0.26
Reintubation (post-hoc crossover analysis) · within 3 days after extubation
P = 0.037
- Reintubation (post-hoc crossover analysis): post-hoc cross-over analysis; 560 vs 421 patients
Effect modification by medical or surgical status (subgroup)
- Medical or surgical status did not modify the effect of NIV on treatment failure
Safety
- No severe adverse events reported
Original publication
Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial. Lancet Respir Med. Published 21 January 2023. doi:10.
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