An interventional study of Non-sedation and Control: Sedation in Delirium and Cognition Disorders, sponsored by Palle Toft. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Palle Toft · Not applicable, Interventional, and Other
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 delirium during admission and cognitive function after discharge from ICU.
Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.
411 studies on the registry are indexed under Cognition Disorders; 90 are open to participants now.
This study's enrollment of 205 is above the median of 60 across 287 interventional studies indexed under Cognition Disorders.
Browse Cognition Disorders studies →Palle Toft is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-sedation supplemented with pain management during mechanical ventilation.
Other: Non-sedation
Current gold standard: Sedation with a daily wake-up trial.
Other: Control: Sedation
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.
Cognitive function
Cognitive t-score, in percentage, difference between the two groups. The t-score for each patient will be diagnosed by the neuropsycologist at a personal interview and use of following tests: * Span of numbers * Coding test * Trailmaking A+B * Rey auditory verbal learning test (immediate, recall) * Rey-Ostherrieth complex figure test (immediate, recall, recognition) * Word finding test (S-word, animals) * Stroop test (congruent+incongruent)
Time frame: 3 months after discharge from ICU
Attention/concentration
T-score in the two groups for the cognitive domaine attention/concentration
Time frame: 3 months after discharge from ICU
Learning/memory
t-score in the two groups for the cognitive domaine: learning/memory
Time frame: 3 months after discharge from ICU
Executive dysfunction
t-score in the two groups for the cognitive domaine: executive dysfunction
Time frame: 3 months after discharge from ICU
Mental pace
t-score in the two groups for the cognitive domaine: mental pace
Time frame: 3 months after discharge from ICU
Hypoactive delirium
Occurrence of hypoactive delirium (RASS ≤ 0, CAM-ICU positive) in each group related to cognitive function at follow up
Time frame: 3 months after discharge from ICU
Agitated delirium
Occurrence of agitated delirium (RASS ≥ +2, CAM-ICU positive) in each group related to cognitive function at follow up
Time frame: 3 months after discharge from ICU
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Palle Toft