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

Study Overview
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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.

Official Title
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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

Conditions
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Stress Disorders, Post-Traumatic, Depression, Anxiety

Intervention / Treatment
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* Other: Non-sedation
* Other: Control, sedation (propofol, midazolam)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-sedation<br>Non-sedation supplemented with pain management during mechanical ventilation. | Other: Non-sedation<br>* Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.<br>|
| Active Comparator: Sedation<br>Current gold standard: Sedation with a daily wake-up trial. | Other: Control, sedation (propofol, midazolam)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD | 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. | 3 months after discharge from ICU | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, Respiration, artificial