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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02034942
Other study ID # S-20130025a
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date March 2019

Study information

Verified date March 2019
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date March 2019
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-sedation

Sedation, control


Locations

Country Name City State
Denmark Lillebaelt Hospital, Kolding Kolding

Sponsors (4)

Lead Sponsor Collaborator
Palle Toft Sygehus Lillebaelt, The Danish Council for Strategic Research, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Biomechanical data Muscle strength - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at ICU-discharge. Within 24 hours of ICU-discharge
Other Handgrip Handgrip-strength at ekstubation and at ICU-discharge. Within 24 hours of ICU-discharge
Other Thigh muscle size Muscle size, measured as cross section area of the rectus femoris muscle at ekstubation and at ICU-discharge Within 24 hours of ICU-discharge
Primary 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.
3 months after ICU-discharge
Secondary 6 minute walk Walking distance in the 6 minute walk test at 3 months follow-up 3 months after ICU-discharge
Secondary Handgrip Handgrip-strength at 3 month follow-up 3 months after ICU-discharge
Secondary Thigh muscle size Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up 3 months after ICU-discharge
Secondary Biomechanical data 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 3 months after ICU-discharge
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