Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
|Critical Illness Length of Stay Respiration, Artificial Intensive Care Units||Procedure: Sedation or no sedation during mechanical ventilation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Advantages and Disadvantages of Long Term Sedation in ICU Patients|
- Time receiving mechanical ventilation, total intensive care and hospital length of stay.
- The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses [ Time Frame: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay ]
|Study Start Date:||April 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
No sedatation intervention
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
No sedation to critically ill patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466492
|Anaesthesiologic-intensive Care Department, Odense University Hospital|
|Odense C, Denmark, 5000|
|Study Chair:||Palle Toft, Professor||Institute of Clinical Research|