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

Critical Illness Clinical Trial

Official title:

Advantages and Disadvantages of Long Term Sedation in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466492
• Other study ID #: 22-6-06
• Status: Completed
• Phase: N/A
• First received: April 26, 2007
• Last updated: March 18, 2010
• Start date: April 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Units
• Length of Stay
• Respiration, Artificial

Intervention

Procedure:
• Sedation or no sedation during mechanical ventilation
No sedation to critically ill patients

Locations

Country	Name	City	State
Denmark	Anaesthesiologic-intensive Care Department, Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. Epub 2003 Oct 2. — View Citation

Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. — View Citation

Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time receiving mechanical ventilation, total intensive care and hospital length of stay.			No
Secondary	The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses		VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay	No

External Links

•   Link to the published paper