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

January 1, 2023 updated by: University Hospital, Ghent

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

Completed

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pre-terminal palliative patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

September 23, 2015

Study Completion (Actual)

September 23, 2015

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

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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