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High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol

Arnaud Thille 1 Grégoire Muller 2 Arnaud Gacouin 3, 4 Rémi Coudroy 5 Alexandre Demoule 6 Romain Sonneville 7 François Beloncle 8 Christophe Girault 9 Laurence Dangers 10, 6 Alexandre Lautrette 11 Séverin Cabasson Anahita Rouzé 12 Emmanuel Vivier 13 Anthony Le Meur Jean-Damien Ricard 14 Keyvan Razazi Guillaume Barberet Christine Lebert 15 Stephan Ehrmann 16 Walter Picard Jeremy Bourenne 17 Gael Pradel 18 Pierre Bailly 19 Nicolas Terzi 20 Matthieu Buscot Guillaume Lacave Pierre-Eric Danin 21 Hodanou Nanadoumgar 5, 22, 23 Aude Gibelin 24 Lassane Zanre Nicolas Deye 25 Stéphanie Ragot 26, 27 Jean-Pierre Frat 28
1 IMRB - Institut Mondor de recherche biomédicale
2 Réanimation Médicale [CHR d'Orléans]
3 CHU Pontchaillou [Rennes]
4 CIC - Centre d'Investigation Clinique [Rennes]
5 CHU Poitiers - Centre hospitalier universitaire de Poitiers
6 CHU Pitié-Salpêtrière [AP-HP]
7 Hôpital Bichat - Claude Bernard
8 MITOVASC - Physiopathologie Cardiovasculaire et Mitochondriale
9 CHU Rouen
10 Neurophysiologie Respiratoire Expérimentale et Clinique
11 Unité de soins intensifs [Clermont Ferrand]
12 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
13 Centre hospitalier Saint Joseph - Saint Luc [Lyon]
14 EEM - Ecologie et Evolution des Microorganismes
15 Service de Réanimation Polyvalente
16 Pathologies Respiratoires : Protéolyse et Aérosolthérapie
17 Service d'anesthésie et de réanimation [Hôpital de la Timone - APHM]
18 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
19 LEPII - Laboratoire d'Économie de la Production et de l'Intégration Internationale
20 CHU Caen
21 Service de Réanimation médico-chirurgicale [Nice]
22 Modélisations pharmacocinétiques-pharmacodynamiques pour un meilleur usage des anti-infectieux
23 Université de Poitiers - Faculté de Médecine et de Pharmacie
24 CHU Tenon [APHP]
25 Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]
26 Pôle DUNE
27 CIC - Poitiers
28 Service de Réanimation Médicale (CHU Poitiers)
Abstract :

INTRODUCTION: Recent practice guidelines suggest applying non-invasive ventilation (NIV) to prevent postextubation respiratory failure in patients at high risk of extubation failure in intensive care unit (ICU). However, such prophylactic NIV has been only a conditional recommendation given the low certainty of evidence. Likewise, high-flow nasal cannula (HFNC) oxygen therapy has been shown to reduce reintubation rates as compared with standard oxygen and to be as efficient as NIV in patients at high risk. Whereas HFNC may be considered as an optimal therapy during the postextubation period, HFNC associated with NIV could be an additional means of preventing postextubation respiratory failure. We are hypothesising that treatment associating NIV with HFNC between NIV sessions may be more effective than HFNC alone and may reduce the reintubation rate in patients at high risk.

METHODS AND ANALYSIS: This study is an investigator-initiated, multicentre randomised controlled trial comparing HFNC alone or with NIV sessions during the postextubation period in patients at high risk of extubation failure in the ICU. Six hundred patients will be randomised with a 1:1 ratio in two groups according to the strategy of oxygenation after extubation. The primary outcome is the reintubation rate within the 7 days following planned extubation. Secondary outcomes include the number of patients who meet the criteria for moderate/severe respiratory failure, ICU length of stay and mortality up to day 90.

ETHICS AND DISSEMINATION: The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT03121482.

Keywords : adult intensive and critical care Clinical trials
Type de document :
Article dans une revue
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https://hal.univ-angers.fr/hal-02616800
Contributeur : Okina Université d'Angers <>
Soumis le : dimanche 24 mai 2020 - 23:39:27
Dernière modification le : mardi 1 septembre 2020 - 03:22:23

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UNIV-ANGERS | UNIV-POITIERS | LEPII | IMRB | U1158 | UPEC-UPEM | UPEC | UNIV-RENNES1 | CIC | PHAR | BIOSIT | CIC203 | UR1-UFR-SVE | COMUE-NORMANDIE | UNIV-RENNES | UNIV-TOURS | SU-MEDECINE | CNRS | UNIV-PARIS13 | CEPN | UNIV-PARIS7 | MITOVASC | USPC | SORBONNE-UNIVERSITE | UGA | UNIV-PARIS

Citation

Arnaud Thille, Grégoire Muller, Arnaud Gacouin, Rémi Coudroy, Alexandre Demoule, et al.. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open, BMJ Publishing Group, 2018, 8 (9), pp.e023772. ⟨10.1136/bmjopen-2018-023772⟩. ⟨hal-02616800⟩

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