Bailly Pierre, Egreteau Pierre-Yves, Ehrmann Stephan, Thille Arnaud W, Guitton Christophe, Grillet Guillaume, Reizine Florian, Huet Olivier, Jaber S, Nowak Emmanuel, L'her Erwan
Médecine Intensive et Réanimation, CHRU de Brest, Brest, Bretagne, France
Réanimation polyvalente, Centre Hospitalier des Pays de Morlaix, Morlaix, France.
BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.
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.
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.
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.
NCT04341350.
在重症监护病房（ICU）使用镇静剂是必要且普遍存在的。镇静策略对预后的影响尚不清楚，尤其是在机械通气开始后早期使用时。越来越多的证据表明，挥发性麻醉剂可能与更好的预后相关。其在预防谵妄方面的应用尚不清楚。
本研究由研究者发起，是一项前瞻性、多中心、双臂、随机、对照、开放试验，比较ICU中机械通气患者的吸入镇静策略与静脉镇静策略。250名患者将被随机分配到静脉镇静组或吸入镇静组，两组根据镇静策略按1:1比例分配。主要结局是使用重症监护病房谵妄评估方法（CAM-ICU）每天两次评估的谵妄发生率。次要结局包括3个月和12个月时的认知和功能结局。
该研究已获得地区伦理委员会（CPP Ouest）和国家当局（ANSM）的批准。研究结果将提交至同行评审期刊发表。
NCT04341350。
