Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Primary Purpose
Critical Illness, Length of Stay, Respiration, Artificial
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sedation or no sedation during mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring 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
Eligibility 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
Sites / Locations
- Anaesthesiologic-intensive Care Department, Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
No sedatation intervention
Arm Description
The intervention group is the normal care in our institution, the control group is the golden standard
Outcomes
Primary Outcome Measures
Time receiving mechanical ventilation, total intensive care and hospital length of stay.
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
Full Information
NCT ID
NCT00466492
First Posted
April 26, 2007
Last Updated
March 18, 2010
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00466492
Brief Title
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Official Title
Advantages and Disadvantages of Long Term Sedation in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Length of Stay, Respiration, Artificial, Intensive Care Units
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No sedatation intervention
Arm Type
Other
Arm Description
The intervention group is the normal care in our institution, the control group is the golden standard
Intervention Type
Procedure
Intervention Name(s)
Sedation or no sedation during mechanical ventilation
Other Intervention Name(s)
Awake, intensive care, Denmark, Mechanical ventilation
Intervention Description
No sedation to critically ill patients
Primary Outcome Measure Information:
Title
Time receiving mechanical ventilation, total intensive care and hospital length of stay.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Palle Toft, Professor
Organizational Affiliation
Institute of Clinical Research
Official's Role
Study Chair
Facility Information:
Facility Name
Anaesthesiologic-intensive Care Department, Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
10816184
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. doi: 10.1056/NEJM200005183422002.
Results Reference
result
PubMed Identifier
14525802
Citation
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. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
Results Reference
result
PubMed Identifier
15187505
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. doi: 10.1097/01.ccm.0000127263.54807.79.
Results Reference
result
PubMed Identifier
22166673
Citation
Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
Results Reference
derived
PubMed Identifier
21542927
Citation
Strom 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. doi: 10.1186/cc10218. Epub 2011 May 4.
Results Reference
derived
PubMed Identifier
20116842
Citation
Strom 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. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
Results Reference
derived
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Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
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