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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
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.

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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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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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