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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040649

Enrollment

205

Registered

2014-01-20

Start date

2014-01-31

Completion date

2019-03-31

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Stress Disorders, Post-Traumatic

Keywords

Critical care, Respiration, artificial

Brief 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.

Interventions

OTHERNon-sedation

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

OTHERControl, 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PTSD	3 months after discharge from ICU	Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria.

Secondary

Measure	Time frame	Description
Patient-reported quality of life	3 months after discharge from ICU	SF-36v2, mental component score for each group. The questionnaire is mailed to the participants, who complete it at home.
Depression	3 months after discharge from ICU	Number of patients in each group diagnosed with depresion by the neuropsycologist, based on personal interview and Beck depression inventory score.
Anxiety	3 months after discarge from ICU	Number of patients in each group diagnosed with anxiety by the neuropsycologist, based on personal interveiw and Beck anxiety inventory score.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026