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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
205
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
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.
Lillebaelt Hospital, Kolding, Intensive Care Unit
Kolding, Denmark
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.
Time frame: 3 months after discharge from ICU
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after discarge from ICU
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