Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial
Introduction The use of sedation in intensive care units (ICUs) is necessary and ubiquitous. The impact of sedation strategy on outcome, particularly when delivered early after initiation of mechanical ventilation, is unknown. Evidence is increasing that volatile anaesthetic agents could be associat...
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BMJ Publishing Group
2021-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/2/e042284.full |
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| author | Emmanuel Nowak Olivier Huet Christophe Guitton Stephan Ehrmann Arnaud W Thille Pierre Bailly Pierre-Yves Egreteau Guillaume Grillet Florian Reizine S Jaber |
| author_facet | Emmanuel Nowak Olivier Huet Christophe Guitton Stephan Ehrmann Arnaud W Thille Pierre Bailly Pierre-Yves Egreteau Guillaume Grillet Florian Reizine S Jaber |
| author_sort | Emmanuel Nowak |
| collection | DOAJ |
| description | Introduction The use of sedation in intensive care units (ICUs) is necessary and ubiquitous. The impact of sedation strategy on outcome, particularly when delivered early after initiation of mechanical ventilation, is unknown. Evidence is increasing that volatile anaesthetic agents could be associated with better outcome. Their use in delirium prevention is unknown.Methods and analysis This study is an investigator-initiated, prospective, multicentre, two-arm, randomised, control, open-trial comparing inhaled sedation strategy versus intravenous sedation strategy in mechanically ventilated patients in ICU. Two hundred and fifty patients will be randomly assigned to the intravenous sedation group or inhaled sedation group, with a 1:1 ratio in two groups according to the sedation strategy. The primary outcome is the occurrence of delirium assessed using two times a day confusion assessment method for the ICU (CAM-ICU). Secondary outcomes include cognitive and functional outcomes at 3 and 12 months.Ethics and dissemination The study has been approved by the Regional Ethics Committee (CPP Ouest) and national authorities (ANSM). The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04341350 |
| format | Article |
| id | doaj-art-32dc9cb2bf1a4001a0626a3346ed167d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-32dc9cb2bf1a4001a0626a3346ed167d2024-11-17T10:20:09ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-042284Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trialEmmanuel Nowak0Olivier Huet1Christophe Guitton2Stephan Ehrmann3Arnaud W Thille4Pierre Bailly5Pierre-Yves Egreteau6Guillaume Grillet7Florian Reizine8S Jaber9Centre Hospitalier Universitaire de Brest, Brest, INSERM Clinical Investigations Centre (CIC) 1412, FranceDépartement d’Anesthésie et Réanimation Chirurgicale, CHU Brest, Brest, FranceMédecine intensive réanimation, Centre Hospitalier de Mans, Le Mans, FranceMédecine Intensive et Réanimation, Centre Hospitalier Régional Universitaire de Tours, Tours, Centre, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceMédecine Intensive Réanimation, CHU de Brest, Brest, FranceService de Réanimation Polyvalente, Centre Hospitalier des Pays de Morlaix, Morlaix, FranceRéanimation polyvalente, Centre Hospitalier de Lorient, Lorient, Bretagne, FranceService de Médecine Intensive et Réanimation, Centre Hospitalier Universitaire de Rennes, Rennes, FranceAnesthesia and Critical Care, Montpellier Univ Hosp, Montpellier, FranceIntroduction The use of sedation in intensive care units (ICUs) is necessary and ubiquitous. The impact of sedation strategy on outcome, particularly when delivered early after initiation of mechanical ventilation, is unknown. Evidence is increasing that volatile anaesthetic agents could be associated with better outcome. Their use in delirium prevention is unknown.Methods and analysis This study is an investigator-initiated, prospective, multicentre, two-arm, randomised, control, open-trial comparing inhaled sedation strategy versus intravenous sedation strategy in mechanically ventilated patients in ICU. Two hundred and fifty patients will be randomly assigned to the intravenous sedation group or inhaled sedation group, with a 1:1 ratio in two groups according to the sedation strategy. The primary outcome is the occurrence of delirium assessed using two times a day confusion assessment method for the ICU (CAM-ICU). Secondary outcomes include cognitive and functional outcomes at 3 and 12 months.Ethics and dissemination The study has been approved by the Regional Ethics Committee (CPP Ouest) and national authorities (ANSM). The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04341350https://bmjopen.bmj.com/content/11/2/e042284.full |
| spellingShingle | Emmanuel Nowak Olivier Huet Christophe Guitton Stephan Ehrmann Arnaud W Thille Pierre Bailly Pierre-Yves Egreteau Guillaume Grillet Florian Reizine S Jaber Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial BMJ Open |
| title | Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial |
| title_full | Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial |
| title_fullStr | Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial |
| title_full_unstemmed | Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial |
| title_short | Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial |
| title_sort | inased inhaled sedation in icu trial protocol a multicentre randomised open label trial |
| url | https://bmjopen.bmj.com/content/11/2/e042284.full |
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