Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034942
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Sygehus Lillebaelt
University of Southern Denmark
The Danish Council for Strategic Research
Information provided by (Responsible Party):
Palle Toft, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Critically Ill Muscular Atrophy Other: Non-sedation Other: Sedation, control Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Non-sedation

The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive.

Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol.

Other: Non-sedation
Active Comparator: Sedation with daily wake-up

The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:

  • Open the eyes to verbal commands.
  • Follow the examiner's instructions with the eyes.
  • Squeeze hands on request.
  • Stick out the tongue on request.

After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4.

Other: Sedation, control
Other Name: Standard treatment, continuous iv-sedation




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034942


Locations
Layout table for location information
Denmark
Lillebaelt Hospital, Kolding
Kolding, Denmark, 6000
Sponsors and Collaborators
Palle Toft
Sygehus Lillebaelt
University of Southern Denmark
The Danish Council for Strategic Research
Investigators
Layout table for investigator information
Principal Investigator: Helene K Nedergaard, MD Lillebaelt Hospital, Kolding
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Palle Toft, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02034942    
Other Study ID Numbers: S-20130025a
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by Palle Toft, Odense University Hospital:
non-sedation
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Atrophy
Critical Illness
Atrophy
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases