Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients - Full Text View

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:

Drug Information available for: Imidacloprid

U.S. FDA Resources

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

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:

Link to the published paper This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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

Strøm T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. Epub 2011 Dec 13.

Strøm T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. Epub 2011 May 4.

Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. Epub 2010 Jan 29.

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
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013