Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol
Methods and analysis The IMPROVE-2 study is a multicentre randomised, parallel-group clinical trial of 680 patients requiring emergency abdominal surgery under general anaesthesia. Patients will be randomly allocated in a 1:1 ratio to receive either low PEEP levels (≤5 cm H2O) without RM or high PEE...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-05-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/5/e054823.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850184919651713024 |
|---|---|
| author | Samir Jaber Emmanuel Futier Karim Asehnoune Bruno Pereira Gerald Chanques Justine Bourdier Thomas Godet Louisa Khaled Lynda Araujo |
| author_facet | Samir Jaber Emmanuel Futier Karim Asehnoune Bruno Pereira Gerald Chanques Justine Bourdier Thomas Godet Louisa Khaled Lynda Araujo |
| author_sort | Samir Jaber |
| collection | DOAJ |
| description | Methods and analysis The IMPROVE-2 study is a multicentre randomised, parallel-group clinical trial of 680 patients requiring emergency abdominal surgery under general anaesthesia. Patients will be randomly allocated in a 1:1 ratio to receive either low PEEP levels (≤5 cm H2O) without RM or high PEEP levels individually adjusted according to driving pressure in addition to RM, stratified by centre and according to the presence of shock and hypoxaemia at randomisation. The primary endpoint is a composite of PRF and all-cause mortality by day 30 or hospital discharge. Data will be analysed on the intention-to-treat principle and a per-protocol basis.Ethics and dissemination IMPROVE-2 trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in February 2021. Results will be submitted for publication in international peer-reviewed journals.Trial registration number NCT03987789. |
| format | Article |
| id | doaj-art-47c5f64fef2b49028f5d06ce4576dbc8 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-47c5f64fef2b49028f5d06ce4576dbc82025-08-20T02:16:55ZengBMJ Publishing GroupBMJ Open2044-60552022-05-0112510.1136/bmjopen-2021-054823Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocolSamir Jaber0Emmanuel Futier1Karim Asehnoune2Bruno Pereira3Gerald Chanques4Justine Bourdier5Thomas Godet6Louisa Khaled7Lynda Araujo8Department of critical care patient acquired muscle weakness, INSERM U1046, Montpellier, France5 Inserm U-1103, Université Clermont Auvergne (UCA), Clermont-Ferrand, France3 Département Anesthésie Réanimation, Centre Hospitalier Universitaire (CHU) Nantes, Nantes, FranceUniversity Hospital CHU Clermont-Ferrand, Clermont-Ferrand, France2 Département Anesthésie Réanimation B (DAR B), Centre Hospitalier Universitaire (CHU) Montpellier, Montpellier, France4 Direction de la Recherche Clinique & Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France1 Departement Anesthésie Réanimation, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Clermont-Ferrand, France1 Departement Anesthésie Réanimation, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Clermont-Ferrand, France4 Direction de la Recherche Clinique & Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, FranceMethods and analysis The IMPROVE-2 study is a multicentre randomised, parallel-group clinical trial of 680 patients requiring emergency abdominal surgery under general anaesthesia. Patients will be randomly allocated in a 1:1 ratio to receive either low PEEP levels (≤5 cm H2O) without RM or high PEEP levels individually adjusted according to driving pressure in addition to RM, stratified by centre and according to the presence of shock and hypoxaemia at randomisation. The primary endpoint is a composite of PRF and all-cause mortality by day 30 or hospital discharge. Data will be analysed on the intention-to-treat principle and a per-protocol basis.Ethics and dissemination IMPROVE-2 trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in February 2021. Results will be submitted for publication in international peer-reviewed journals.Trial registration number NCT03987789.https://bmjopen.bmj.com/content/12/5/e054823.full |
| spellingShingle | Samir Jaber Emmanuel Futier Karim Asehnoune Bruno Pereira Gerald Chanques Justine Bourdier Thomas Godet Louisa Khaled Lynda Araujo Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol BMJ Open |
| title | Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol |
| title_full | Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol |
| title_fullStr | Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol |
| title_full_unstemmed | Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol |
| title_short | Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol |
| title_sort | intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery the multicentre prospective randomised improve 2 study protocol |
| url | https://bmjopen.bmj.com/content/12/5/e054823.full |
| work_keys_str_mv | AT samirjaber intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT emmanuelfutier intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT karimasehnoune intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT brunopereira intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT geraldchanques intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT justinebourdier intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT thomasgodet intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT louisakhaled intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol AT lyndaaraujo intraoperativeprotectivemechanicalventilationinpatientsrequiringemergencyabdominalsurgerythemulticentreprospectiverandomisedimprove2studyprotocol |