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

March 18, 2010 updated by: Odense University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Anaesthesiologic-intensive Care Department, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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:
  • Mechanical ventilation
  • Awake
  • intensive care
  • Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time receiving mechanical ventilation, total intensive care and hospital length of stay.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Chair: Palle Toft, Professor, Institute of Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-6-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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