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| Name | Class |
|---|---|
| Kolding Sygehus | OTHER |
| University of Southern Denmark | OTHER |
| The Danish Council for Strategic Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-sedation | Experimental | Non-sedation supplemented with pain management during mechanical ventilation. |
|
| Sedation | Active Comparator | Current gold standard: Sedation with a daily wake-up trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-sedation | Other | Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 months after discharge from ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Attention/concentration | T-score in the two groups for the cognitive domaine attention/concentration | 3 months after discharge from ICU |
| Learning/memory | t-score in the two groups for the cognitive domaine: learning/memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Joergensen, MD | Lillebaelt Hospital, Kolding | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lillebaelt Hospital, Kolding, Intensive Care Unit | Kolding | 6000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27250658 | Derived | Nedergaard HK, Jensen HI, Stylsvig M, Lauridsen JT, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial. Trials. 2016 Jun 1;17(1):269. doi: 10.1186/s13063-016-1390-5. |
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| Control: Sedation | Other | 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. |
|
| 3 months after discharge from ICU |
| Executive dysfunction | t-score in the two groups for the cognitive domaine: executive dysfunction | 3 months after discharge from ICU |
| Mental pace | t-score in the two groups for the cognitive domaine: mental pace | 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 | 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 | 3 months after discharge from ICU |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003072 | Cognition Disorders |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
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