Cognition Disorders, Delirium
Conditions
Keywords
Respiration, artificial, Critcal care
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 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.
Interventions
OTHERNon-sedation
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
OTHERControl: Sedation
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.
Sponsors
Palle Toft
Kolding Sygehus
University of Southern Denmark
The Danish Council for Strategic Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 |
|---|---|---|
| Cognitive function | 3 months after discharge from ICU | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Learning/memory | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: learning/memory |
| Executive dysfunction | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: executive dysfunction |
| Attention/concentration | 3 months after discharge from ICU | T-score in the two groups for the cognitive domaine attention/concentration |
| Hypoactive delirium | 3 months after discharge from ICU | Occurrence of hypoactive delirium (RASS ≤ 0, CAM-ICU positive) in each group related to cognitive function at follow up |
| Agitated delirium | 3 months after discharge from ICU | Occurrence of agitated delirium (RASS ≥ +2, CAM-ICU positive) in each group related to cognitive function at follow up |
| Mental pace | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: mental pace |
Countries
Denmark
Outcome results
None listed