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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.
BMJ Open. 2018 09 05; 8(9):e023772.BO

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.

Authors+Show Affiliations

Department of Réanimation Médicale, CHU de Poitiers, Poitiers, France. Université de Poitiers, INSERM CIC 1402 ALIVE, Poitiers, France.Médecine Intensive Réanimation, Groupe Hospitalier Régional d'Orléans, Orléans, France.Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes, Hôpital Ponchaillou, Rennes, France.Department of Réanimation Médicale, CHU de Poitiers, Poitiers, France. Université de Poitiers, INSERM CIC 1402 ALIVE, Poitiers, France.Service de Pneumologie et Réanimation Médicale du Département R3S, AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France.Hôpital Bichat - Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France.Département de Médecine Intensive - Réanimation, Université d'Angers, CHU d'Angers, Angers, France.Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), CHU de Rouen, Hôpital Charles Nicolle, Rouen, France.Service de Réanimation Polyvalente, CHU Félix Guyon, Saint Denis de la Réunion, France.Service de Réanimation Médicale, CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, France.Service de Réanimation, Centre hospitalier de la Rochelle, La Rochelle, Nouvelle-Aquitaine, France.Centre de Réanimation, Université de Lille, CHU de Lille, Lille, France.Reanimation Polyvalente, Hôpital Saint Joseph Saint Luc, Lyon, France.Médecine Intensive Réanimation, CHU de Nantes, Nantes, France.Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Hopital Louis-Mourier, Colombes, France.Service de Réanimation Médicale DHU A-TVB, AP-HP, Hopitaux Universitaires Henri Mondor, Creteil, Île-de-France, France.Service de Réanimation Médicale, Groupe Hospitalier Régional Mulhouse Sud Alsace, Site Emile Muller, Mulhouse, France.Service de Médecine Intensive et Réanimation, Centre Hospitalier Départemental de Vendée, La Roche-sur-Yon, France.CHU de Tours, Médecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France.Service de Réanimation, Centre Hospitalier de Pau, Pau, France.CHU La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.Service de Réanimation, Centre Hospitalier Henri Mondor d'Aurillac, Aurillac, France.Médecine Intensive Réanimation, CHU de Brest, Brest, France.Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.Réanimation Médicale Archet 1, Université Cote d'Azur, CHU de Nice, Nice, France.Service de Réanimation Médico-Chirurgicale, Centre Hospitalier de Versailles, Le Chesnay, France.Réanimation Médico-Chirurgicale Archet 2, INSERM U 1065, CHU de Nice, Nice, France.Réanimation Chirurgicale, CHU de Poitiers, Poitiers, France.Réanimation et USC médico-chirurgicale, CARMAS, AP-HP, Faculté de Médecine Sorbonne Université, Collegium Galilée, Hopital Tenon, Paris, France.Service de Réanimation, Centre Hospitalier Emile Roux, Le Puy-en-Velay, France.Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Hopital Lariboisiere, Paris, France.Université de Poitiers, INSERM CIC 1402 ALIVE, Poitiers, France.Department of Réanimation Médicale, CHU de Poitiers, Poitiers, France. Université de Poitiers, INSERM CIC 1402 ALIVE, Poitiers, France.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30185583

Citation

Thille, Arnaud W., 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, vol. 8, no. 9, 2018, pp. e023772.
Thille AW, Muller G, Gacouin A, 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. 2018;8(9):e023772.
Thille, A. W., Muller, G., Gacouin, A., Coudroy, R., Demoule, A., Sonneville, R., Beloncle, F., Girault, C., Dangers, L., Lautrette, A., Cabasson, S., Rouzé, A., Vivier, E., Le Meur, A., Ricard, J. D., Razazi, K., Barberet, G., Lebert, C., Ehrmann, S., ... Frat, J. P. (2018). 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, 8(9), e023772. https://doi.org/10.1136/bmjopen-2018-023772
Thille AW, 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. 2018 09 5;8(9):e023772. PubMed PMID: 30185583.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Thille,Arnaud W, AU - Muller,Grégoire, AU - Gacouin,Arnaud, AU - Coudroy,Rémi, AU - Demoule,Alexandre, AU - Sonneville,Romain, AU - Beloncle,François, AU - Girault,Christophe, AU - Dangers,Laurence, AU - Lautrette,Alexandre, AU - Cabasson,Séverin, AU - Rouzé,Anahita, AU - Vivier,Emmanuel, AU - Le Meur,Anthony, AU - Ricard,Jean-Damien, AU - Razazi,Keyvan, AU - Barberet,Guillaume, AU - Lebert,Christine, AU - Ehrmann,Stephan, AU - Picard,Walter, AU - Bourenne,Jeremy, AU - Pradel,Gael, AU - Bailly,Pierre, AU - Terzi,Nicolas, AU - Buscot,Matthieu, AU - Lacave,Guillaume, AU - Danin,Pierre-Eric, AU - Nanadoumgar,Hodanou, AU - Gibelin,Aude, AU - Zanre,Lassane, AU - Deye,Nicolas, AU - Ragot,Stéphanie, AU - Frat,Jean-Pierre, AU - ,, Y1 - 2018/09/05/ PY - 2018/9/7/entrez PY - 2018/9/7/pubmed PY - 2019/10/23/medline KW - adult intensiv & critical care KW - clinical trials SP - e023772 EP - e023772 JF - BMJ open JO - BMJ Open VL - 8 IS - 9 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/30185583/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_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=30185583 DB - PRIME DP - Unbound Medicine ER -