We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768416
First Posted: January 15, 2013
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  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 ]
    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 ]
    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 ]
    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 ]
  • 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.


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768416


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

Locations
Belgium
University Hospital Ghent 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

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01768416     History of Changes
Other Study ID Numbers: 2012/895
First Submitted: January 11, 2013
First Posted: January 15, 2013
Last Update Posted: June 3, 2015
Last Verified: June 2015

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