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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034942
• Other study ID #: S-20130025a
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrophy
• Critical Illness
• Critically Ill
• Muscular Atrophy

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