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

Not Applicable

Completed

• Conditions: Critical Illness; Length of Stay; Respiration, Artificial; Intensive Care Units
• Interventions: Procedure: Sedation or no sedation during mechanical ventilation

• Registration Number: NCT00466492
• Lead Sponsor: Odense University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Study First Posted: 2007-04-27
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Intubated receiving mechanical ventilation
• Expected to remain intubated more than 24 hours
• Over 18 years

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Exclusion Criteria

• Raised intracranial pressure
• Pregnant
• Treatment with muscle relaxants

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No sedatation intervention	Sedation or no sedation during mechanical ventilation	The intervention group is the normal care in our institution, the control group is the golden standard

Primary Outcome Measures

Name	Time	Method
Time receiving mechanical ventilation, total intensive care and hospital length of stay.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Anaesthesiologic-intensive Care Department, Odense University Hospital; 🇩🇰 Odense C, Denmark