NCT02040649

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

Substudy of the NONSEDA-trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Posttraumatic Stress Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Palle Toft · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Stress Disorders, Post-Traumatic
• Depression
• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-06-01
• Completion: 2019-03-01
• First posted: 2014-01-20
• Last updated: 2019-03-15

Locations

1 site across 1 country: Denmark