- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768416
Measuring Depth of Unconsciousness at the End of Life Using Bispectral Index (BIS) (BISSOPS)
Measuring Depth of Unconsciousness at the End of Life: the Reliability of the BIS Monitoring as an Assessment Tool Versus Sedation Scales
The purpose of this study is to use the BIS monitor to assess the degree of consciousness in pre-terminal palliative patients admitted to our palliative care unit and to ascertain if this tool provides a more accurate assessment of consciousness in this specific group of patients than clinical observation of consciousness and the use of sedation scales.
We hypothesize that the measured BIS results provide a more accurate assessment of the patient's level of consciousness than routine clinical observation or the use of sedation scales.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pre-terminal palliative patients with a life expectancy of 72 hours or less at the start of the observation.
Exclusion Criteria:
- lack of consent of patient or representative
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring the accuracy of BIS monitoring in assessing the evolution of the level of consciousness in pre-terminal patients
Time Frame: 72 hours
|
Measuring the accuracy of BIS monitoring in assessing the evolution of the level of consciousness in pre-terminal patients with a life expectancy of 72 hours or less from the moment of the first clinical signs of dying and loss of consciousness until the moment of death.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determining the evolution of BIS values, measured in pre-terminal patients
Time Frame: 72 hours
|
Determining the evolution of BIS values, measured in pre-terminal patients with a life expectancy of 72 hours or less from the moment of the first clinical signs of dying and loss of consciousness until the moment of death.
|
72 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determining the evolution of sedation scores, measured with the Observer's Assessment of Alertness/Sedation scale and the Richmond Agitation and Sedation Scale in pre-terminal patients
Time Frame: 72 hours
|
Determining the evolution of sedation scores, measured with the Observer's Assessment of Alertness/Sedation scale and the Richmond Agitation and Sedation Scale in pre-terminal patients admitted to a palliative care unit with a life expectancy of 72 hours or less.
|
72 hours
|
Determining if and in what degree the measured BIS values correspond to the measured sedation scores.
Time Frame: 72 hours
|
72 hours
|
|
Determining if there is a noticeable difference between the BIS scores and sedation scale scores of patients with medically induced sedation
Time Frame: 72 hours
|
Determining if there is a noticeable difference between the BIS scores and sedation scale scores of patients with medically induced sedation and those of patients losing consciousness as part of a normal dying process.
|
72 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martine De Laat, MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/895
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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