Critically Ill, Muscular Atrophy
Conditions
Keywords
non-sedation
Brief summary
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.
Interventions
OTHERNon-sedation
OTHERSedation, control
Sponsors
Sygehus Lillebaelt
University of Southern Denmark
The Danish Council for Strategic Research
Palle Toft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip | 3 months after ICU-discharge | Handgrip-strength at 3 month follow-up |
| 6 minute walk | 3 months after ICU-discharge | Walking distance in the 6 minute walk test at 3 months follow-up |
| Thigh muscle size | 3 months after ICU-discharge | Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up |
| Biomechanical data | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thigh muscle size | Within 24 hours of ICU-discharge | Muscle size, measured as cross section area of the rectus femoris muscle at ekstubation and at ICU-discharge |
| Handgrip | Within 24 hours of ICU-discharge | Handgrip-strength at ekstubation and at ICU-discharge. |
| Biomechanical data | 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. |
Countries
Denmark
Outcome results
None listed