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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Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.

Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.

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Detailed Description

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Conditions

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Stress Disorders, Post-Traumatic Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Non-sedation

Non-sedation supplemented with pain management during mechanical ventilation.

Group Type EXPERIMENTAL

Non-sedation

Intervention Type OTHER

Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.

Sedation

Current gold standard: Sedation with a daily wake-up trial.

Group Type ACTIVE_COMPARATOR

Control, sedation (propofol, midazolam)

Intervention Type OTHER

Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.

Interventions

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Non-sedation

Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.

Intervention Type OTHER

Control, sedation (propofol, midazolam)

Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.

Intervention Type OTHER

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
* Patient does not speak Danish, swedish or norwegian at a reasonable level

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No