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

Not Applicable

Completed

• Conditions: Anxiety; Stress Disorders, Post-Traumatic; Depression
• Interventions: Other: Control, sedation (propofol, midazolam); Other: Non-sedation

• Registration Number: NCT02040649
• Lead Sponsor: Palle Toft

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2017-06
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedation	Control, sedation (propofol, midazolam)	Current gold standard: Sedation with a daily wake-up trial.
Non-sedation	Non-sedation	Non-sedation supplemented with pain management during mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Lillebaelt Hospital, Kolding, Intensive Care Unit; 🇩🇰 Kolding, Denmark