Critically Ill Clinical Trial
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
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 |
Verified date | March 2019 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Lillebaelt Hospital, Kolding | Kolding |
Lead Sponsor | Collaborator |
---|---|
Palle Toft | Sygehus Lillebaelt, The Danish Council for Strategic Research, University of Southern Denmark |
Denmark,
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
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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