Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care

Study Overview
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Brief Summary
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The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD). Hypothesis 1: Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated Hypothesis 2: Former delirious patients are more likely to develop PTSD Hypothesis 3: Delirium decreases health-related quality (HRQoL) of life after discharge

Detailed Description
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Background: It is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital. Methods according to hypothesis 1: During ICU stay: Measure sedation level & delirium. First follow-up 1-2 weeks after ICU: Memories Analyses: Data will be analyzed descriptive via EPIDATA and Stata Delirium is endpoint, defined as CAM-ICU positive. Sedation level is exposure variable. Confounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex. Correlation between sedation level and memories will be calculated. Methods according to hypothesis 2: Screening for: PTSD, Depression, Anxiety Analyses: PTSD is endpoint, and delirium is the exposure variable. Main confounders: Anxiety and Depression Mean of PTSD will be calculated with Confidence Interval to test any difference between experienced delirium or not. Methods according to hypothesis 3: Method:Health-related quality of life is endpoint, Activities of daily living (ADL), Memories, and a Script Test (only after 2 month) Analyses: Mean of HRQoL will be calculated with Confidence Interval to test any difference between experienced delirium or not. Confounders: Diary and/or Follow up

Official Title
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Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?

Conditions
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Delirium, Stress Disorders, Post-Traumatic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU-stay > 48 hours Exclusion Criteria: Severe brain trauma Non-Danish-speaking Age < 18 years Death (only hypothesis 2 and 3 in the study)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation level and Delirium | Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU | At least twice a day while in the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Traumatic Stress Disorder | Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer these questionnaires: Intensive Care Unit - memory tool Harvard Trauma Questionnaire (HTQ) Major Depression Inventory (MDI) State-Trait Anxiety Inventory Form Y (STAI) | 2 and 6 month after ICU-discharge | 
| Health-related quality of life | Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer the questionnaires: Activities of daily living (ADL) Short-form 36 Script Test (only after 2 month) | 2 and 6 month after ICU-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Delirium, PTSD, Depression, Anxiety, HRQoL, CAM-ICU, RASS, SF-36, ICU-memory tool, Antipsychotic Agents, Mobilization, ICU-nursing, ICU, intensive care, critical care, critical care nursing