Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial.

Background: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.

[There is a need for further studies exploring the sleep in patients during intensive care unit admission].

We have been reviewing the literature on sleep in intensive care unit (ICU) patients, concluding that lack of normal sleep is a common problem. Polysomnography studies have demonstrated sleep deprivation and fragmentation. Delirium commonly coincides with sleep deprivation and shares the same symptoms.