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Trial record 26 of 81692 for:    measured

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

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ClinicalTrials.gov Identifier: NCT01768416
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : January 15, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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 or disease
Loss of Consciousness at End of Life.

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Study Type : Observational
Estimated Enrollment : 30 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.

  2. Determining if and in what degree the measured BIS values correspond to the measured sedation scores. [ Time Frame: 72 hours ]
  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Locations
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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
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Principal Investigator: Martine De Laat, MD University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01768416     History of Changes
Other Study ID Numbers: 2012/895
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms