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

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

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

Study Overview

• Status: Completed
• Conditions: Delirium; Stress Disorders, Post-Traumatic

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital, Århus Sygehus
  • Hillerød, Denmark, 3400
    • Anæstesiologisk Afdeling, . Hillerød Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients at the ICUs ITA and 600 at Århus Sygehus, Denmark from September 2009 and at Hillerød Intensive, Denmark from 15th October 2010 to 1st October 2011.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Novo Nordic Foundation
• Investigators: Study Chair: Else Tønnesen, MD Professor, Dept. of Anasthesia, Aarhus Universtyhospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 22, 2012
• Last Update Submitted That Met QC Criteria: October 19, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: PTSD; Depression; critical care; Anxiety; ICU; intensive care; Sedation; SF-36; Antipsychotic Agents; Delirium; Mobilization; CAM-ICU; HRQoL; RASS; critical care nursing; ICU-memory tool; ICU-nursing
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Trauma and Stressor Related Disorders; Delirium; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1-16-02-50-09