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)
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 pos...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e042619.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846152012570296320 |
|---|---|
| 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 René Robert |
| author_facet | 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 René Robert |
| author_sort | Christophe Guitton |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-dee092735e464a26809f53f1e9e74340 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-dee092735e464a26809f53f1e9e743402024-11-27T01:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-042619T-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)Christophe Guitton0Rémi Coudroy1Jean-Pierre Frat2Stephan Ehrmann3Nicolas Terzi4Gwenaël Prat5Damien Contou6Jeremy Bourenne7Arnaud Gacouin8Jean Dellamonica9Jean-Pierre Quenot10Jérôme Devaquet11Emmanuel Vivier12Stéphanie Ragot13Arnaud W Thille14Mai-Anh Nay15Laurence Dangers16Antoine Romen17Guillaume Lacave18Béatrice Lacombe19Jean Reignier20Gaetan Beduneau21Anahita Rouze22Agathe Delbove23Nicholas Sedillot24Jean-Paul Mira25Alexandre Lautrette26Laurent Argaud27Quentin Levrat28Marie-Ange Azais29Christophe Leroy30Martin Dres31René Robert32Médecine intensive réanimation, Centre Hospitalier de Mans, Le Mans, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceMédecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d`étude des pathologies respiratoires, INSERM U1100, Université de Tours, Centre Hospitalier Régional Universitaire de Tours, Tours, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, Rhône-Alpes, FranceMédecine Intensive Réanimation, CHU de Brest, Brest, FranceService de Réanimation Polyvalente, Centre Hospitalier d`Argenteuil, Argenteuil, FranceMédecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, CHU La Timone 2, Marseille, FranceService des maladies infectieuses et réanimation médicale, Centre Hospitalier Universitaire de Rennes, Rennes, FranceMedical ICU, University Hospital Centre Nice, Nice, FranceRéanimation médicale, Centre Hospitalier Universitaire de Dijon, Dijon, FranceMedical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, FranceService de Réanimation Polyvalente, Centre Hospitalier Saint Joseph-Saint Luc, Lyon, FranceBiostatistics, INSERM 1402, Poitiers, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceMedical Intensive Care Unit, Centre Hospitalier Regional d`Orleans, Orleans, FranceService de Réanimation Polyvalente, Centre Hospitalier Universitaire Félix Guyon, Saint-Denis, La Réunion, RéunionRéanimation polyvalente, CH de Pau, Pau, FranceService de Réanimation Médico-Chirurgicale, Centre Hospitalier de Versailles, Le Chesnay, Île-de-France, FranceService de Réanimation polyvalente, Groupe Hospitalier Bretagne Sud, Lorient , FranceMédecine intensive réanimation, CHU Nantes, Nantes, FranceDépartement de Réanimation Médicale, Centre Hospitalier Universitaire de Rouen, Rouen, FranceCentre de Réanimation, Université de Lille, Centre Hospitalier Universitaire de Lille, Lille, Hauts-de-France, FranceRéanimation, Centre Hospitalier Bretagne Atlantique, Vannes, FranceHôpital Fleyriat, Réanimation Polyvalente, Centre Hospitalier de Bourg-en-Bresse, Bourg-en-Bresse, FranceService de Médecine Intensive Réanimation, Hôpital Cochin, Paris, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand Site Gabriel-Montpied, Clermont-Ferrand, FranceIntensive Care, Hospices Civils de Lyon, Lyon, FranceService de Réanimation, Centre hospitalier de la Rochelle, La Rochelle, Nouvelle-Aquitaine, FranceService de Médecine Intensive et Réanimation, Centre Hospitalier Departmental La Roche-sur-Yon, La Roche-sur-Yon, Pays de la Loire, FranceService de Médecine Intensive Réanimation, Centre Hospitalier Emile Roux, Le Puy en Velay, FranceService de Médecine intensive Réanimation, Hôpital Pitie Salpêtrière, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceIntroduction 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.https://bmjopen.bmj.com/content/10/11/e042619.full |
| spellingShingle | 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 René Robert 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 |
| 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/11/e042619.full |
| work_keys_str_mv | AT christopheguitton tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT remicoudroy tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeanpierrefrat tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT stephanehrmann tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT nicolasterzi tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT gwenaelprat tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT damiencontou tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeremybourenne tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT arnaudgacouin tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeandellamonica tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeanpierrequenot tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeromedevaquet tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT emmanuelvivier tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT stephanieragot tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT arnaudwthille tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT maianhnay tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT laurencedangers tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT antoineromen tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT guillaumelacave tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT beatricelacombe tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeanreignier tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT gaetanbeduneau tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT anahitarouze tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT agathedelbove tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT nicholassedillot tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT jeanpaulmira tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT alexandrelautrette tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT laurentargaud tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT quentinlevrat tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT marieangeazais tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT christopheleroy tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT martindres tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex AT renerobert tpieceversuspressuresupportventilationforspontaneousbreathingtrialsbeforeextubationinpatientsathighriskofreintubationprotocolforamulticentrerandomisedcontrolledtrialtipex |