Skip to main content
OpenTrials
Completed

NCT Number: NCT02034942

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critically Ill Atrophy Critical Illness Disease Attributes Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillebaelt Hospital, Kolding

Kolding, 6000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-sedation

Other

Sedation, control

Other

Other names: Standard treatment, continuous iv-sedation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 6 minute walk

    Time frame: 3 months after ICU-discharge

    Walking distance in the 6 minute walk test at 3 months follow-up

  2. Handgrip

    Time frame: 3 months after ICU-discharge

    Handgrip-strength at 3 month follow-up

  3. 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

  4. 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

Other outcomes

  1. 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.

  2. Handgrip

    Time frame: Within 24 hours of ICU-discharge

    Handgrip-strength at ekstubation and at ICU-discharge.

  3. 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

Sponsors and collaborators

Lead sponsor

Palle Toft

Other

Collaborators

  • Sygehus Lillebaelt
  • The Danish Council for Strategic Research
  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jan 14, 2014
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.