Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02035436|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : March 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Delirium Cognition Disorders||Other: Non-sedation Other: Control: Sedation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||March 2019|
Non-sedation supplemented with pain management during mechanical ventilation.
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
Active Comparator: Sedation
Current gold standard: Sedation with a daily wake-up trial.
Other: Control: 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.
- 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)
- Attention/concentration [ Time Frame: 3 months after discharge from ICU ]T-score in the two groups for the cognitive domaine attention/concentration
- Learning/memory [ Time Frame: 3 months after discharge from ICU ]t-score in the two groups for the cognitive domaine: learning/memory
- Executive dysfunction [ Time Frame: 3 months after discharge from ICU ]t-score in the two groups for the cognitive domaine: executive dysfunction
- Mental pace [ Time Frame: 3 months after discharge from ICU ]t-score in the two groups for the cognitive domaine: mental pace
- Hypoactive delirium [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035436
|Lillebaelt Hospital, Kolding, Intensive Care Unit|
|Kolding, Denmark, 6000|
|Principal Investigator:||Helene Joergensen, MD||Lillebaelt Hospital, Kolding|