Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients

Study Overview
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Brief Summary
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The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.

Detailed Description
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The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials. We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital. We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.

Official Title
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Advantages and Disadvantages of Long Term Sedation in ICU Patients

Conditions
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Critical Illness, Length of Stay, Respiration, Artificial, Intensive Care Units

Intervention / Treatment
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* Procedure: Sedation or no sedation during mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intubated receiving mechanical ventilation Expected to remain intubated more than 24 hours Over 18 years Exclusion Criteria: Raised intracranial pressure Pregnant Treatment with muscle relaxants

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No sedatation intervention<br>The intervention group is the normal care in our institution, the control group is the golden standard | Procedure: Sedation or no sedation during mechanical ventilation<br>* No sedation to critically ill patients<br>* Other names: Mechanical ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time receiving mechanical ventilation, total intensive care and hospital length of stay. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses |  | VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Administration Schedule, Intensive Care Units, Length of Stay, Respiration, Artificial, Stress Disorders, Post-Traumatic/etiology/*psychology, Critical Illness/*psychology, Pneumonia/prevention & control, Hypnotics and Sedatives/*administration & dosage