title: Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial.
abstract: The effects of non-sedation on cognitive function in critically ill patients on mechanical ventilation are not yet certain. This trial is a substudy of the NONSEDA trial where critically ill patients are randomized to non-sedation or to sedation with a daily wake-up attempt during mechanical ventilation in the intensive care unit (ICU). The aim of this substudy is to assess the effects of non-sedation versus sedation with a daily wake-up attempt on long-term cognitive function.
  
  
  
  This is an investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 200 patients. Inclusion criteria will be adult patients who are intubated and on mechanical ventilation with an expected duration of more than 24 hours. Exclusion criteria will be patients who are comatose at admission and patients with conditions requiring therapeutic coma (i.e., severe head trauma, status epilepticus, patients treated with therapeutic hypothermia and patients with severe hypoxia). The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up attempt. The primary outcome will be cognitive function 3 months after discharge from intensive care. The secondary outcomes will be the results of seven specific cognitive tests, performed 3 months after discharge from intensive care, and the association between hypoactive and agitated delirium during ICU admission and long-term cognitive function.
  
  
  
  If non-sedation can improve long-term cognitive function, it could be an approach worth considering for a larger group of critically ill patients.
  
  
  
  The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02035436 , registered on 10 January 2014).
authors.affiliation: Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Skovvangen 2-8, DK-6000, Kolding, Denmark. helene.korvenius.nedergaard@rsyd.dk.
authors.forename: Helene Korvenius
authors.initials: HK
authors.lastname: Nedergaard
authors.affiliation: Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Skovvangen 2-8, DK-6000, Kolding, Denmark.
authors.forename: Hanne Irene
authors.initials: HI
authors.lastname: Jensen
authors.affiliation: , Haugstedgaardsvej 5, 5230, Odense M, Region of Southern Denmark.
authors.forename: Mette
authors.initials: M
authors.lastname: Stylsvig
authors.affiliation: Centre of Health Economics Research, Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.
authors.forename: Jørgen T
authors.initials: JT
authors.lastname: Lauridsen
authors.affiliation: Department of Anesthesiology and Intensive Care, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.
authors.forename: Palle
authors.initials: P
authors.lastname: Toft
mesh_terms: D002985:Clinical Protocols; D003071:Cognition; D016292:Procedural Sedation; D016638:Critical Illness; D003625:Data Collection; D006801:Humans; D012121:Respiration, Artificial
keywords: Cognitive disorders; Critical care/methods; Critical illness/rehabilitation; Delirium; Intensive care