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

NCT02034942 | Completed DMC

• 1 other identifier: S-20130025a
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Muscular Atrophy

Keywords

non-sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 6 minute walk

  3 months after ICU-discharge

• Handgrip

  3 months after ICU-discharge

• Thigh muscle size

  3 months after ICU-discharge

• Biomechanical data

  3 months after ICU-discharge

Other Outcomes (3)

• Biomechanical data

  Within 24 hours of ICU-discharge

• Handgrip

  Within 24 hours of ICU-discharge

• Thigh muscle size

  Within 24 hours of ICU-discharge

Study Arms (2)

Non-sedation

EXPERIMENTAL

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

Sedation with daily wake-up

ACTIVE COMPARATOR

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

Interventions

Non-sedation OTHER

Non-sedation

Sedation, control OTHER

Also known as: Standard treatment, continuous iv-sedation

Sedation with daily wake-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endotracheally intubated
• Expected time on ventilator \> 24 hours
• Age ≥ 18 years
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Palle Toft: lead
• Sygehus Lillebaelt: collaborator
• University of Southern Denmark: collaborator
• The Danish Council for Strategic Research: collaborator

Study Sites (1)

Lillebaelt Hospital, Kolding

Kolding, 6000, Denmark

Location

Related Publications (3)

• Strom 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.

  PMID: 20116842 BACKGROUND

• Nedergaard HK, Jensen HI, Olsen HT, Strom T, Lauridsen JT, Sjogaard G, Toft P. Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial. J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.

  PMID: 33276294 DERIVED

• Nedergaard HK, Jensen HI, Lauridsen JT, Sjogaard G, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.

  PMID: 26201718 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Helene K Nedergaard, MD

  Lillebaelt Hospital, Kolding

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

DK (1)