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1. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX)

Author

Jean-Paul Mira, Jeremy Bourenne, Agathe Delbove, René Robert, Gaetan Beduneau, Jean-Pierre Frat, Jérôme Devaquet, Arnaud Gacouin, Laurence Dangers, Nicolas Terzi, Stéphanie Ragot, Guylaine Labro, Antoine Romen, Gael Pradel, Christophe Leroy, Jean Reignier, Laurent Argaud, Rémi Coudroy, Quentin Levrat, Stephan Ehrmann, Jean-Pierre Quenot, Emmanuel Vivier, Guillaume Lacave, Christophe Guitton, Marie-Ange Azais, Alexandre Lautrette, Mai-Anh Nay, Anahita Rouzé, Damien Contou, Martin Dres, Gwenaël Prat, Jean Dellamonica, Arnaud W. Thille, Nicholas Sedillot, Béatrice Lacombe, Université de Lille, CNRS, Centre hospitalier universitaire de Poitiers [CHU Poitiers], CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Tours [CHRU Tours], Centre Hospitalier Victor Dupouy, Centre hospitalier Félix-Guyon [Saint-Denis, La Réunion], Centre hospitalier de Pau, Centre Hospitalier Le Mans (CH Le Mans), Centre Hospitalier de Versailles André Mignot [CHV], CHU Dijon, CIC - CHU Henri Mondor, Centre Hospitalier Universitaire [Grenoble] [CHU], CHRU Brest - Service de Réanimation Médicale [CHU - BREST - Réa Med], Centre Hospitalier Emile Muller [Mulhouse] [CH E.Muller Mulhouse], Centre hospitalier universitaire de Nantes [CHU Nantes], Service d'anesthésie et réanimation chirurgicale [Nantes], Service de réanimation médicale [CHU Rouen], Centre Hospitalier Universitaire de Nice [CHU Nice], Centre Hospitalier Régional d'Orléans [CHRO], Centre Hospitalier Régional Universitaire [Lille] [CHRU Lille], Centre hospitalier Bretagne Atlantique (Morbihan) [CHBA], Hôpital Cochin [AP-HP], Hôpital de la Timone [CHU - APHM] [TIMONE], Centre Jean Perrin [Clermont-Ferrand] [UNICANCER/CJP], Hôpital Edouard Herriot [CHU - HCL], Hôpital Foch [Suresnes], Centre hospitalier Saint Joseph - Saint Luc [Lyon], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon [CHD Vendée], Centre Hospitalier Emile Roux [AP-HP], INSERM CIC 0802 [INSERM - CHU de Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Pathologies Respiratoires : Protéolyse et Aérosolthérapie, Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire Félix-Guyon [Saint-Denis, La Réunion, France], Centre Hospitalier de Versailles André Mignot (CHV), Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Groupe Hospitalier Bretagne Sud (GHBS), Centre Hospitalier Henri Mondor d'Aurillac, Unité de soins intensifs médicaux [CHU Grenoble], Centre Hospitalier Universitaire [Grenoble] (CHU), Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), CHRU Brest - Service de Réanimation Médicale (CHU - BREST - Réa Med), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Emile Muller [Mulhouse] (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Hôpital Charles Nicolle [Rouen], Unité de Recherche Clinique de la Côte d’Azur [Nice] (URRIS UR2CA), Université Côte d'Azur (UCA), Centre Hospitalier Universitaire de Nice (CHU Nice), Centre Hospitalier Régional d'Orléans (CHRO), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), Centre Hospitalier Fleyriat [Bourg en Bresse], Unité de Soins Intensifs [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital de la Timone [CHU - APHM] (TIMONE), Aix Marseille Université (AMU), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Hospices Civils de Lyon (HCL), Centre Hospitalier de La Rochelle (CHR), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), REVA research network, CarMeN, laboratoire, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de Recherche Clinique de la Côte d’Azur (URRIS UR2CA), Centre Hospitalier Universitaire de Nice (CHU Nice)-Université Côte d'Azur (UCA), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
medicine.medical_treatment, [SDV]Life Sciences [q-bio], Pressure support ventilation, law.invention, Spontaneous breathing trial, Positive-Pressure Respiration, 03 medical and health sciences, Work of breathing, 0302 clinical medicine, Randomized controlled trial, law, Informed consent, medicine, respiratory medicine (see thoracic medicine), Humans, 030212 general & internal medicine, adult intensive & critical care, respiratory physiology, Mechanical ventilation, business.industry, Intensive Care, General Medicine, Intensive care unit, Respiration, Artificial, 3. Good health, [SDV] Life Sciences [q-bio], 030228 respiratory system, Anesthesia, Breathing, Airway Extubation, Medicine, France, business, Ventilator Weaning
Abstract

IntroductionIn intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.Methods and analysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.Ethics and disseminationThe study has been approved by the central ethics committee ‘Ile de France V’ (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04227639.

Published
2020
Full Text
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2. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX)

Author

Christophe Guitton, Rémi Coudroy, Jean-Pierre Frat, Stephan Ehrmann, Nicolas Terzi, Gwenaël Prat, Damien Contou, Jeremy Bourenne, Arnaud Gacouin, Jean Dellamonica, Jean-Pierre Quenot, Jérôme Devaquet, Emmanuel Vivier, Stéphanie Ragot, Arnaud W Thille, Mai-Anh Nay, Laurence Dangers, Antoine Romen, Guillaume Lacave, Béatrice Lacombe, Jean Reignier, Gaetan Beduneau, Anahita Rouze, Agathe Delbove, Nicholas Sedillot, Jean-Paul Mira, Alexandre Lautrette, Laurent Argaud, Quentin Levrat, Marie-Ange Azais, Christophe Leroy, Martin Dres, and René Robert

Subjects
Medicine
Abstract

Introduction In intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.Methods and analysis This study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.Ethics and dissemination The study has been approved by the central ethics committee ‘Ile de France V’ (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04227639.

Published
2020
Full Text
View/download PDF

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