| Title: |
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) |
| Authors: |
Thille, A. W.; Coudroy, R.; Gacouin, A.; Ehrmann, S.; Contou, D.; Dangers, L.; Romen, A.; Guitton, C.; Lacave, G.; Quenot, J. P.; Lacombe, B.; Pradel, G.; Terzi, N.; Prat, G.; Labro, G.; Reignier, J.; Beduneau, G.; Dellamonica, J.; Nay, M. A.; Rouze, A.; Delbove, A.; Sedillot, N.; Mira, J. P.; Bourenne, J.; Lautrette, A.; Argaud, L.; Levrat, Q.; Devaquet, J.; Vivier, E.; Azais, M. A.; Leroy, C.; Dres, M.; Robert, R.; Ragot, S.; Frat, J. P. |
| Contributors: |
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); CIC de Poitiers – Centre d'investigation clinique de Poitiers (CIC 1402) (CIC 1402); Université de Poitiers = University of Poitiers (UP)-Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Centre d’Investigation Clinique CHRU Tours (CIC 1415); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre d’Etude des Pathologies Respiratoires Tours (CEPR - U 1100); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre hospitalier Victor Dupouy Centre hospitalier d'Argenteuil (CH Argenteuil); 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); 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 (CH Aurillac); Unité de soins intensifs médicaux CHU Grenoble; CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire (HP2); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes 2016-2019 (UGA 2016-2019 ); 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 = Nantes University Hospital (CHU Nantes); Service de Réanimation Médicale CHU Rouen; Hôpital Charles Nicolle Rouen; CHU Rouen; Normandie Université (NU)-Normandie Université (NU)-CHU Rouen; Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN); Normandie Université (NU); Normandie Université (NU)-Normandie Université (NU); Unité de Recherche Clinique Côte d’Azur (UR2CA); Centre Hospitalier Universitaire de Nice (CHU Nice)-Université Côte d'Azur (UniCA); Université Côte d'Azur (UniCA); Centre Hospitalier Universitaire de Nice (CHU Nice); Centre Hospitalier Regional d'Orléans (CHRO); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA); Centre Hospitalier Fleyriat Bourg en Bresse (CHBBF); 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; Hôpital Edouard Herriot CHU - HCL; Hospices Civils de Lyon (HCL); Centre Hospitalier de La Rochelle (CHR); 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 Le Puy-en-Velay (CH Le Puy); CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); REVA research network |
| Source: |
EISSN: 2044-6055 ; BMJ Open ; https://inserm.hal.science/inserm-03268241 ; BMJ Open, 2020, 10 (11), pp.e042619. ⟨10.1136/bmjopen-2020-042619⟩ |
| Publisher Information: |
CCSD; BMJ Publishing Group |
| Publication Year: |
2020 |
| Collection: |
Université François-Rabelais de Tours: HAL |
| Subject Terms: |
adult intensive & critical care; respiratory medicine (see thoracic medicine); respiratory physiology; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/33234658; PUBMED: 33234658; PUBMEDCENTRAL: PMC7689072 |
| DOI: |
10.1136/bmjopen-2020-042619 |
| Availability: |
https://inserm.hal.science/inserm-03268241; https://inserm.hal.science/inserm-03268241v1/document; https://inserm.hal.science/inserm-03268241v1/file/e042619.full.pdf; https://doi.org/10.1136/bmjopen-2020-042619 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.FBBE5D2D |
| Database: |
BASE |