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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Critically Ill Muscular Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Non-sedation

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Sedation, control

Intervention Type OTHER

Interventions

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Non-sedation

Intervention Type OTHER

Sedation, control

Intervention Type OTHER

Other Intervention Names

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Standard treatment, continuous iv-sedation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No