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Measuring Depth of Unconsciousness at the End of Life Using Bispectral Index (BIS) (BISSOPS)

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01768416
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition
Loss of Consciousness at End of Life.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Depth of Unconsciousness at the End of Life: the Reliability of the BIS Monitoring as an Assessment Tool Versus Sedation Scales

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Measuring the accuracy of BIS monitoring in assessing the evolution of the level of consciousness in pre-terminal patients [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Determining the evolution of BIS values, measured in pre-terminal patients [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Determining if and in what degree the measured BIS values correspond to the measured sedation scores. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pre-terminal palliative patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768416

Contacts
Contact: Martine De Laat, MD martine.delaat@Ugent.be

Locations
Belgium
University Hospital Ghent Not yet recruiting
Ghent, Belgium, 9000
Contact: Martine De Laat, MD         martine.delaat@Ugent.be    
Principal Investigator: Martine De Laat, MD            
Sub-Investigator: Eric Mortier, Phd, MD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Martine De Laat, MD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01768416     History of Changes
Other Study ID Numbers: 2012/895
Study First Received: January 11, 2013
Last Updated: January 11, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013