Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function
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|ClinicalTrials.gov Identifier: NCT02034942|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : March 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Muscular Atrophy||Other: Non-sedation Other: Sedation, control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Substudy of Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||March 2019|
The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive.
Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol.
Active Comparator: Sedation with daily wake-up
The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:
After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4.
Other: Sedation, control
Other Name: Standard treatment, continuous iv-sedation
- Physical function [ Time Frame: 3 months after ICU-discharge ]
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.
- 6 minute walk [ Time Frame: 3 months after ICU-discharge ]Walking distance in the 6 minute walk test at 3 months follow-up
- Handgrip [ Time Frame: 3 months after ICU-discharge ]Handgrip-strength at 3 month follow-up
- Thigh muscle size [ Time Frame: 3 months after ICU-discharge ]Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up
- Biomechanical data [ Time Frame: 3 months after ICU-discharge ]Muscle strength, measured using biomechanical measurements - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at 3 months follow-up
- Biomechanical data [ Time Frame: Within 24 hours of ICU-discharge ]Muscle strength - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at ICU-discharge.
- Handgrip [ Time Frame: Within 24 hours of ICU-discharge ]Handgrip-strength at ekstubation and at ICU-discharge.
- Thigh muscle size [ Time Frame: Within 24 hours of ICU-discharge ]Muscle size, measured as cross section area of the rectus femoris muscle at ekstubation and at ICU-discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034942
|Lillebaelt Hospital, Kolding|
|Kolding, Denmark, 6000|
|Principal Investigator:||Helene K Nedergaard, MD||Lillebaelt Hospital, Kolding|