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 Cognitive Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Cognitive function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Non-sedation
Non-sedation supplemented with pain management during mechanical ventilation.
Intervention: Non-sedation (Other)
Sedation
Current gold standard: Sedation with a daily wake-up trial.
Intervention: Control: Sedation (Other)
Outcomes
Primary Outcomes
Cognitive function
Time Frame: 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 Outcomes
- Attention/concentration(3 months after discharge from ICU)
- Learning/memory(3 months after discharge from ICU)
- Executive dysfunction(3 months after discharge from ICU)
- Agitated delirium(3 months after discharge from ICU)
- Mental pace(3 months after discharge from ICU)
- Hypoactive delirium(3 months after discharge from ICU)
Investigators
Palle Toft
Professor
Odense University Hospital