Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial - The Lancet

1 year ago 59

Summary

Background

Non-invasive ventilation (NIV) and oxygen therapy (high-flow nasal oxygen [HFNO] or modular oxygen) pursuing extubation person ne'er been compared successful critically sick patients with obesity. We aimed to comparison NIV (alternating with HFNO oregon modular oxygen) and oxygen therapy (HFNO oregon modular oxygen) pursuing extubation of critically sick patients with obesity.

Methods

In this multicentre, parallel group, pragmatic randomised controlled trial, conducted successful 39 intensive attraction units successful France, critically sick patients with obesity undergoing extubation were randomly assigned (1:1) to either the NIV radical oregon the oxygen therapy group. Two randomisations were performed: first, randomisation to either NIV oregon oxygen therapy, and second, randomisation to either HFNO oregon modular oxygen (also 1:1), which was nested wrong the archetypal randomisation. Blinding of the randomisation was not possible, but the statistician was masked to radical assignment. The superior result was treatment nonaccomplishment wrong 3 days aft extubation, a composite of reintubation for mechanical ventilation, power to the different survey treatment, oregon premature discontinuation of survey treatment. The superior result was analysed by volition to treat. Effect of aesculapian and surgical presumption was assessed. The reintubation wrong 3 days was analysed by volition to dainty and aft a post-hoc crossover analysis. This survey is registered with ClinicalTrials.gov, fig NCT04014920.

Findings

From Oct 2, 2019, to July 17, 2021, of the 1650 screened patients, 981 were enrolled. Treatment nonaccomplishment occurred successful 66 (13·5%) of 490 patients successful the NIV radical and successful 130 (26·5%) of 491 patients successful the oxygen-therapy radical (relative hazard 0·43; 95% CI 0·31–0·60, p<0·0001). Medical oregon surgical presumption did not modify the effect of NIV radical connected the treatment-failure rate. Reintubation wrong 3 days aft extubation was akin in the non-invasive ventilation radical and successful the oxygen therapy radical successful the intention-to-treat investigation (48 (10%) of 490 patients and 59 (12%) of 491 patients, p=0·26) and lower successful the NIV radical than successful the oxygen-therapy radical successful the post-hoc cross-over (51 (9%) of 560 patients and 56 (13%) of 421 patients, p=0·037) analysis. No terrible adverse events were reported.

Interpretation

Among critically sick adults with obesity undergoing extubation, the usage of NIV was effectual to trim treatment-failure wrong 3 days. Our results are applicable to clinical practice, supporting the usage of NIV aft extubation of critically sick patients with obesity. However, astir of the quality successful the superior result was owed to patients successful the oxygen therapy radical switching to NIV, and much grounds is needed to conclude that an NIV strategy leads to improved patient-centred outcomes.

Funding

French Ministry of Health.

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Article Info

Publication History

Published: January 21, 2023

Identification

DOI: https://doi.org/10.1016/S2213-2600(22)00529-X

Copyright

© 2022 Elsevier Ltd. All rights reserved.

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