Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial
- Type de publi. : Article dans une revue
- Date de publi. : 01/01/2023
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Auteurs :
Audrey de JongAnne BignonFrançois StéphanThomas GodetJean-Michel ConstantinKarim AsehnouneAude SylvestreJuliette SautilletRaiko BlondonnetMartine FerrandierePhilippe SeguinSigismond LasockiAmélie RolléPierre-Marie FayolleLaurent MullerEmmanuel PardoNicolas TerziSeverin RaminBoris JungPaër-Sélim AbbackPhilippe GuerciBenjamine SartonHadrien RozéClaire DupuisJoel CoussonMarion FaucherVirginie LemialeBernard CholleyGerald ChanquesFouad BelafiaHelena HuguetEmmanuel FutierÉlie AzoulayNicolas MolinariSamir JaberRoman CalypsoAstrid Bouteau-DurandMichel CarlesHossen MehdaouiBertrand SouweineLaure CalvetMatthieu JabaudonBenjamin RieuClara CandilleFlorian SigaudBeatrice RiuLaurent PapazianSabine ValeraDjamel MokartLaurent Chow ChineMagali BisbalCamille PouliquenJean-Manuel de GuibertMaxime TourretDamien MalletMarc LeoneLaurent ZieleskiewiczJeanne CossicMona AssefiElodie BaronCyril QuemeneurAntoine MonselMatthieu BiaisAlexandre OuattaraEline BonnardelSimon MonziolsMartin MahulJean-Yves LefrantClaire RogerSaber BarbarFabien LambiottePiehr Saint-LegerCatherine PaugamJulien PottecherPierre-Olivier LudesLucie DarrivereMarc GarnierEric KipnisGilles LebuffeMatthias GarotJeremy FalconeBenjamin ChoustermanMagali ColletEtienne GayatJean DellamonicaWilly-Serge MfamEvelina OchinMohamed NebliNejla TiloucheBenjamin MadeuxDavid BougonYassir AarabFanny Garnier
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Organismes :
Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
Centre Hospitalier Régional Universitaire [Montpellier]
Centre Hospitalier Régional Universitaire [CHU Lille]
Hypertension pulmonaire : physiopathologie et innovation thérapeutique
Hôpital Marie-Lannelongue
CHU Clermont-Ferrand
CHU Pitié-Salpêtrière [AP-HP]
Groupe de Recherche Clinique en Anesthésie Réanimation médecine PEriopératoire
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre d'études et de recherche sur les services de santé et la qualité de vie
Hôpital Nord [CHU - APHM]
Centre Hospitalier de la Polynésie Française
CHU Clermont-Ferrand
Centre Hospitalier Régional Universitaire de Tours
Université de Tours
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Nutrition, Métabolismes et Cancer
Centre Hospitalier Universitaire d'Angers
Université d'Angers
CHU Pointe-à-Pitre / Abymes [Guadeloupe]
Centre Hospitalier Universitaire de Martinique [Fort-de-France, Martinique]
Centre Hospitalier Universitaire de Nîmes
Groupe de Recherche Clinique en Anesthésie Réanimation médecine PEriopératoire
CHU Saint-Antoine [AP-HP]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Centre Hospitalier Régional Universitaire [Montpellier]
Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
Centre Hospitalier Régional Universitaire [Montpellier]
Hôpital Beaujon [AP-HP]
Centre Hospitalier Régional Universitaire de Nancy
Centre Hospitalier Universitaire de Toulouse
Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
Centre Hospitalier Universitaire de Bordeaux
CHU Clermont-Ferrand
Hôpital universitaire Robert Debré [Reims]
Institut Paoli-Calmettes
Hopital Saint-Louis [AP-HP]
Hôpital Européen Georges Pompidou [APHP]
Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
Centre Hospitalier Régional Universitaire [Montpellier]
Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
Centre Hospitalier Régional Universitaire [Montpellier]
Institut Montpelliérain Alexander Grothendieck
Centre Hospitalier Régional Universitaire [Montpellier]
CHU Clermont-Ferrand
Hopital Saint-Louis [AP-HP]
Institut Desbrest d'Epidémiologie et de Santé Publique
Médecine de précision par intégration de données et inférence causale
Institut Montpelliérain Alexander Grothendieck
Centre Hospitalier Régional Universitaire [Montpellier]
Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
Centre Hospitalier Régional Universitaire [Montpellier]
- Publié dans The Lancet Respiratory Medicine le 23/10/2020
Résumé : Background : Non-invasive ventilation (NIV) and oxygen therapy (high-flow nasal oxygen [HFNO] or standard oxygen) following extubation have never been compared in critically ill patients with obesity. We aimed to compare NIV (alternating with HFNO or standard oxygen) and oxygen therapy (HFNO or standard oxygen) following extubation of critically ill patients with obesity. Methods : In this multicentre, parallel group, pragmatic randomised controlled trial, conducted in 39 intensive care units in France, critically ill patients with obesity undergoing extubation were randomly assigned (1:1) to either the NIV group or the oxygen therapy group. Two randomisations were performed: first, randomisation to either NIV or oxygen therapy, and second, randomisation to either HFNO or standard oxygen (also 1:1), which was nested within the first randomisation. Blinding of the randomisation was not possible, but the statistician was masked to group assignment. The primary outcome was treatment failure within 3 days after extubation, a composite of reintubation for mechanical ventilation, switch to the other study treatment, or premature discontinuation of study treatment. The primary outcome was analysed by intention to treat. Effect of medical and surgical status was assessed. The reintubation within 3 days was analysed by intention to treat and after a post-hoc crossover analysis. This study is registered with ClinicalTrials.gov number NCT04014920. Findings : From Oct 2, 2019, to July 17, 2021, of the 1650 screened patients, 981 were enrolled. Treatment failure occurred in 66 (13·5%) of 490 patients in the NIV group and in 130 (26·5%) of 491 patients in the oxygen-therapy group (relative risk 0·43; 95% CI 0·31–0·60, p<0·0001). Medical or surgical status did not modify the effect of NIV group on the treatment-failure rate. Reintubation within 3 days after extubation was similar in the non-invasive ventilation group and in the oxygen therapy group in the intention-to-treat analysis (48 (10%) of 490 patients and 59 (12%) of 491 patients, p=0·26) and lower in the NIV group than in the oxygen-therapy group in the post-hoc cross-over (51 (9%) of 560 patients and 56 (13%) of 421 patients, p=0·037) analysis. No severe adverse events were reported. Interpretation : Among critically ill adults with obesity undergoing extubation, the use of NIV was effective to reduce treatment-failure within 3 days. Our results are relevant to clinical practice, supporting the use of NIV after extubation of critically ill patients with obesity. However, most of the difference in the primary outcome was due to patients in the oxygen therapy group switching to NIV, and more evidence is needed to conclude that an NIV strategy leads to improved patient-centred outcomes.
Fichiers liés :
2023 De jong et al., Effect of non.pdf
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