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

Measuring Depth of Unconsciousness at the End of Life: the Reliability of the BIS Monitoring as an Assessment Tool Versus Sedation Scales

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01768416

Acronym

BISSOPS

Enrollment

Registered

2013-01-15

Start date

2013-03-01

Completion date

2015-09-23

Last updated

2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of Consciousness at End of Life

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Measuring the accuracy of BIS monitoring in assessing the evolution of the level of consciousness in pre-terminal patients	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

Measure	Time frame	Description
Determining the evolution of BIS values, measured in pre-terminal patients	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

Measure	Time frame	Description
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	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.	72 hours	—
Determining if there is a noticeable difference between the BIS scores and sedation scale scores of patients with medically induced sedation	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.

Countries

Belgium

Outcome results