Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function

N/ACompletedNCT02034942

Palle Toft205 enrolled

Overview

Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength. Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU. Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

205

Conditions

Critically Ill Muscular Atrophy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Endotracheally intubated * Expected time on ventilator \> 24 hours * Age ≥ 18 years * Informed consent Exclusion Criteria: * Severe head trauma where therapeutic coma is indicated * Therapeutic hypothermia where therapeutic coma is indicated * Status epilepticus where therapeutic coma is indicated * Patient has participated in the study before * Patient is transferred from another ICU with length of stay \> 48 hours * Patient is comatose at admission * PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation

Outcomes

Primary Outcomes

Physical function

Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index. Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025.