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) - Inserm - Institut national de la santé et de la recherche médicale Access content directly
Journal Articles BMJ Open Year : 2020

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)

1 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
2 CIC 1402 - CIC Poitiers – Centre d'investigation clinique de Poitiers
3 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
4 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
5 CIC - Centre d’Investigation Clinique [Tours] CIC 1415
6 PRPA - Pathologies Respiratoires : Protéolyse et Aérosolthérapie
7 Centre Hospitalier Victor Dupouy
8 Centre Hospitalier Universitaire Félix-Guyon [Saint-Denis, La Réunion, France]
9 Centre hospitalier de Pau
10 Centre Hospitalier Le Mans (CH Le Mans)
11 CHV - Centre Hospitalier de Versailles André Mignot
12 Service de Réanimation Médicale (CHU de Dijon)
13 GHBS - Groupe Hospitalier Bretagne Sud
14 Centre Hospitalier Henri Mondor d'Aurillac
15 Unité de soins intensifs médicaux [CHU Grenoble]
16 HP2 - Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire
17 CHU - BREST - Réa Med - CHRU Brest - Service de Réanimation Médicale
18 CH E.Muller Mulhouse - Centre Hospitalier Emile Muller [Mulhouse]
19 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
20 Service de Réanimation Médicale [CHU Rouen]
21 Hôpital Charles Nicolle [Rouen]
22 URRIS UR2CA - Unité de Recherche Clinique de la Côte d’Azur
23 UniCA - Université Côte d'Azur
24 CHU Nice - Centre Hospitalier Universitaire de Nice
25 CHRO - Centre Hospitalier Régional d'Orléans
26 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
27 CHBA - Centre hospitalier Bretagne Atlantique (Morbihan)
28 CHBBF - Centre Hospitalier Fleyriat [Bourg en Bresse]
29 Unité de Soins Intensifs [CHU Cochin]
30 TIMONE - Hôpital de la Timone [CHU - APHM]
31 AMU - Aix Marseille Université
32 UNICANCER/CJP - Centre Jean Perrin [Clermont-Ferrand]
33 Hôpital Edouard Herriot [CHU - HCL]
34 Centre Hospitalier de La Rochelle (CHR)
35 Hôpital Foch [Suresnes]
36 Centre hospitalier Saint Joseph - Saint Luc [Lyon]
37 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
38 Centre Hospitalier Emile Roux [AP-HP]
39 CHU Pitié-Salpêtrière [AP-HP]
A. Lautrette
C. Leroy

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.
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Dates and versions

inserm-03268241 , version 1 (23-06-2021)

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A. W. Thille, R. Coudroy, A. Gacouin, S. Ehrmann, D. Contou, et al.. 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). BMJ Open, 2020, 10 (11), pp.e042619. ⟨10.1136/bmjopen-2020-042619⟩. ⟨inserm-03268241⟩
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