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
  Purpose

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


Condition Intervention
Critical Illness
Length of Stay
Respiration, Artificial
Intensive Care Units
Procedure: Sedation or no sedation during mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Advantages and Disadvantages of Long Term Sedation in ICU Patients

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Time receiving mechanical ventilation, total intensive care and hospital length of stay. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00466492

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Strøm, Anaesthesiologic-intensive unit, Odens University Hospital
ClinicalTrials.gov Identifier: NCT00466492     History of Changes
Other Study ID Numbers: 22-6-06
Study First Received: April 26, 2007
Last Updated: March 18, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014