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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00466492
First received: April 26, 2007
Last updated: March 18, 2010
Last verified: June 2009

April 26, 2007
March 18, 2010
April 2007
May 2009   (final data collection date for primary outcome measure)
Time receiving mechanical ventilation, total intensive care and hospital length of stay. [ Designated as safety issue: No ]
• Time receiving mechanical ventilation, intensive care and hospital length of stay.
Complete list of historical versions of study NCT00466492 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
• The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses
Not Provided
Not Provided
 
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Advantages and Disadvantages of Long Term Sedation in ICU Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Critical Illness
  • Length of Stay
  • Respiration, Artificial
  • Intensive Care Units
Procedure: Sedation or no sedation during mechanical ventilation
No sedation to critically ill patients
Other Names:
  • Awake
  • intensive care
  • Denmark
  • Mechanical ventilation
No sedatation intervention
The intervention group is the normal care in our institution, the control group is the golden standard
Intervention: Procedure: Sedation or no sedation during mechanical ventilation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00466492
22-6-06
No
Thomas Strøm, Anaesthesiologic-intensive unit, Odens University Hospital
Odense University Hospital
Not Provided
Study Chair: Palle Toft, Professor Institute of Clinical Research
Odense University Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP