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| Name | Class |
|---|---|
| Kolding Sygehus | OTHER |
| The Danish Council for Strategic Research | OTHER |
| University of Southern Denmark | 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 posttraumatic stress disorder after discharge from ICU.
Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder 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 |
|---|---|---|
| PTSD | Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria. | 3 months after discharge from ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported quality of life | SF-36v2, mental component score for each group. The questionnaire is mailed to the participants, who complete it at home. | 3 months after discharge from ICU |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Nedergaard, 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 |
|---|---|---|---|
| 22166673 | Background | Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13. |
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| Control, sedation (propofol, midazolam) | 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. |
|
Number of patients in each group diagnosed with depresion by the neuropsycologist, based on personal interview and Beck depression inventory score.
| 3 months after discharge from ICU |
| Anxiety | Number of patients in each group diagnosed with anxiety by the neuropsycologist, based on personal interveiw and Beck anxiety inventory score. | 3 months after discarge from ICU |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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