Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00466492|
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : March 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Length of Stay Respiration, Artificial Intensive Care Units||Procedure: Sedation or no sedation during mechanical ventilation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advantages and Disadvantages of Long Term Sedation in ICU Patients|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466492
|Anaesthesiologic-intensive Care Department, Odense University Hospital|
|Odense C, Denmark, 5000|
|Study Chair:||Palle Toft, Professor||Institute of Clinical Research|