Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial

Pierre Bailly, Pierre-Yves Egreteau, Stephan Ehrmann, Arnaud W Thille, Christophe Guitton, Guillaume Grillet, Florian Reizine, Olivier Huet, S Jaber, Emmanuel Nowak, Erwan L'her, Pierre Bailly, Pierre-Yves Egreteau, Stephan Ehrmann, Arnaud W Thille, Christophe Guitton, Guillaume Grillet, Florian Reizine, Olivier Huet, S Jaber, Emmanuel Nowak, Erwan L'her

Abstract

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.

Keywords: adult anaesthesia; adult intensive & critical care; delirium & cognitive disorders.

Conflict of interest statement

Competing interests: PB reports financial support (travel expanse coverage to attend scientific meetings) from Sedana Medical. SE declares receiving consulting fees, unrestricted research grants and equipment research support from Aerogen, unrestricted research grant from Fisher & Paykel, unrestricted research grant form Hamilton medical, consulting fees from La Diffusion Technique Française. AWT reports financial support (payment for lectures and travel expanse coverage to attend scientific meetings) from Fisher & Paykel, Covidien, Maquet-Getinge and GE Healthcare. SJ reports receiving consulting fees from Drager, Medtronic, Baxter,Fresenius Medical and Fisher & Paykel. EL is cofounder and shareholder of Oxynov, a R and D Canadian company dedicated to automated oxygen administration. He is also a consultant for Sedana Medical, GE Healthcare and Smiths Medical.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Intervention. Patients who are eligible for inclusion will be randomised and assigned to one of the two groups (inhaled or intravenous sedation). outcomes will be evaluated during ICU stay, at discharge and at 3 and 12 months. ICU, intensive care unit.

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