Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial.


Journal

The Lancet. Respiratory medicine
ISSN: 2213-2619
Titre abrégé: Lancet Respir Med
Pays: England
ID NLM: 101605555

Informations de publication

Date de publication:
04 2019
Historique:
received: 31 10 2018
revised: 14 12 2018
accepted: 19 12 2018
pubmed: 23 3 2019
medline: 18 4 2020
entrez: 23 3 2019
Statut: ppublish

Résumé

Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation. The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoing tracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4·2%, 95% CI -13·7 to 5·5; p=0·39). In the 242 patients with moderate-to-severe hypoxaemia (PaO In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline. French Ministry of Health.

Sections du résumé

BACKGROUND
Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation.
METHODS
The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoing tracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO
FINDINGS
Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4·2%, 95% CI -13·7 to 5·5; p=0·39). In the 242 patients with moderate-to-severe hypoxaemia (PaO
INTERPRETATION
In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline.
FUNDING
French Ministry of Health.

Identifiants

pubmed: 30898520
pii: S2213-2600(19)30048-7
doi: 10.1016/S2213-2600(19)30048-7
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02668458']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

303-312

Investigateurs

Delphine Chatellier (D)
Florence Boissier (F)
Anne Veinstein (A)
René Robert (R)
Céline Deletage-Métreau (C)
Morgane Olivry (M)
Claire Dahyot-Fizelier (C)
Auguste Dargent (A)
Audrey Large (A)
Emmanuelle Begot (E)
Claire Mancia (C)
Maxence Decavele (M)
Martin Dres (M)
Samuel Lehingue (S)
Laurent Papazian (L)
Marine Paul (M)
Nathalie Marin (N)
Matthieu Le Meur (M)
Mohammed Laissy (M)
Anaita Rouzé (A)
Saad Nseir (S)
Matthieu Henry-Lagarrigue (M)
Aihem Yehia (A)
Frédéric Martino (F)
Charles Cerf (C)
Pierre Bailly (P)
Julie Helms (J)
Jean Baptiste Putegnat (JB)
Armand Mekontso-Dessap (A)
Thierry Boulain (T)
Pierre Asfar (P)
Séverin Cabasson (S)
Florent Wallet (F)
Kada Klouche (K)
Frédéric Bellec (F)
Delphine Chatellier (D)
Florence Boissier (F)
Anne Veinstein (A)
René Robert (R)
Céline Deletage-Métreau (C)
Morgane Olivry (M)
Maxence Decavele (M)
Martin Dres (M)
Samuel Lehingue (S)
Laurent Papazian (L)
Matthieu Le Meur (M)
Mohammed Laissy (M)
Anaita Rouzé (A)
Saad Nseir (S)
Matthieu Henry-Lagarrigue (M)
Aihem Yehia (A)
Charles Cerf (C)
Armand Mekontso-Dessap (A)
Thierry Boulain (T)
Pierre Asfar (P)

Commentaires et corrections

Type : CommentIn
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Informations de copyright

Copyright © 2019 Elsevier Ltd. All rights reserved.

Auteurs

Jean-Pierre Frat (JP)

CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. Electronic address: jean-pierre.frat@chu-poitiers.fr.

Jean-Damien Ricard (JD)

Assistance Publique des Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, Colombes, France; Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Paris, France.

Jean-Pierre Quenot (JP)

CHU Dijon Bourgogne, Service de Médecine Intensive Réanimation, Dijon, France; Université Bourgogne Franche-Comté Lipness Team, UMR 1231 et INSERM CIC 1432 Epidémiologie Clinique, Dijon, France.

Nicolas Pichon (N)

CHU Dupuytren, Réanimation Polyvalente, Limoges, France.

Alexandre Demoule (A)

Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.

Jean-Marie Forel (JM)

Réanimation des Détresses Respiratoires et Infections Sévères, Hôpital Nord-Assistance Publique-Hôpitaux de Marseille, Marseille, France; Aix-Marseille Université, Marseille, France.

Jean-Paul Mira (JP)

Assistance Publique des Hôpitaux de Paris, Groupe Hospitalier Universitaire de Paris Centre, Hôpital Cochin, Réanimation Médicale, Paris, France; Faculté de Médecine, Université Paris Descartes, Paris, France.

Rémi Coudroy (R)

CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France.

Guillaume Berquier (G)

Assistance Publique des Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, Colombes, France; Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Paris, France.

Benoit Voisin (B)

CHRU de Lille, Centre de Réanimation, Lille, France.

Gwenhaël Colin (G)

Centre Hospitalier Départemental de La Roche sur Yon, Service de Réanimation Polyvalente, La Roche sur Yon, France.

Bertrand Pons (B)

Service de Réanimation, CHU Point-à-Pitre, Pointe-à-Pitre, Guadeloupe, France.

Pierre Eric Danin (PE)

Réanimation Chirurgicale, CHU de Nice, Nice, France; INSERM U1065, Team 8, C3M, Nice, France.

Jérome Devaquet (J)

Hôpital Foch, Réanimation Polyvalente, Suresnes, France.

Gwenael Prat (G)

CHU de la Cavale Blanche, Service de Réanimation Médicale, Brest, France.

Raphaël Clere-Jehl (R)

Service de Réanimation, Nouvel Hôpital Civil, Strasbourg, France; Université de Strasbourg, Faculté de Médecine, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.

Franck Petitpas (F)

CHU Poitiers, Réanimation Chirurgicale, Poitiers, France.

Emmanuel Vivier (E)

Centre Hospitalier Saint Joseph-Saint Luc, Service de Réanimation Polyvalente, Lyon, France.

Keyvan Razazi (K)

Assistance Publique des Hôpitaux de Paris, CHU Henri Mondor, DHU A-TVB, Service de Réanimation Médicale, Créteil, France; Université Paris Est Créteil, Faculté de Médecine de Créteil, Groupe de Recherche Clinique CARMAS, Créteil, France; INSERM, Unité UMR 955, IMRB, Créteil France.

Mai-Anh Nay (MA)

Centre Hospitalier Régional d'Orléans, Service de Médecine Intensive réanimation, Orléans, France.

Vincent Souday (V)

CHU Angers, Service de Réanimation Médicale et Médecine Hyperbare, Angers, France.

Jean Dellamonica (J)

CHU Nice, Service de Médecine Intensive et Réanimation, Nice, France.

Laurent Argaud (L)

Hospices Civils de Lyon, Groupement Hospitalier Universitaire Edouard Herriot, Service de Réanimation Médicale, Lyon, France.

Stephan Ehrmann (S)

CHRU de Tours, Médecine Intensive Réanimation, Tours, France; Université de Tours, Centre d'Etudes des Pathologies Respiratoires, INSERM U1100, Tours, France.

Aude Gibelin (A)

Assistance Publique des Hôpitaux de Paris, Hôpital Tenon, Service de Réanimation, pneumologique, Paris, France.

Christophe Girault (C)

Normandie Univ, UNIROUEN, Department of Medical Intensive Care, Charles Nicolle University, Rouen, France; CHU de Rouen, Rouen, France; EA3830-GRHV, Institute for Research and Innovation in Biomedicine, Rouen University, Rouen, France.

Pascal Andreu (P)

CHU Dijon Bourgogne, Service de Médecine Intensive Réanimation, Dijon, France.

Philippe Vignon (P)

CHU Dupuytren, Réanimation Polyvalente, Limoges, France; Clinical Investigation Centre INSERM 1435, Limoges, France.

Laurence Dangers (L)

Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France.

Stéphanie Ragot (S)

Biostatistics, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France.

Arnaud W Thille (AW)

CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France.

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Classifications MeSH