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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
Sponsor:
Information provided by:
Odense University Hospital

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

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009
Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Awake
  • intensive care
  • Denmark
  • Mechanical ventilation


Outcome Measures
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Primary Outcome Measures :
  1. Time receiving mechanical ventilation, total intensive care and hospital length of stay.

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Anaesthesiologic-intensive Care Department, Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Palle Toft, Professor Institute of Clinical Research
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Strøm, Anaesthesiologic-intensive unit, Odens University Hospital
ClinicalTrials.gov Identifier: NCT00466492    
Other Study ID Numbers: 22-6-06
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: June 2009
Keywords provided by Odense University Hospital:
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
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes