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

NCT02040649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2019-03-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Non-sedation

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

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.

Sponsors & Collaborators

  • Kolding Sygehus

    collaborator OTHER

  • The Danish Council for Strategic Research

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Palle Toft

    lead OTHER

Principal Investigators

  • Helene Nedergaard, MD · Lillebaelt Hospital, Kolding

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-06-30
Completion
2019-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040649 on ClinicalTrials.gov