Completed

NCT Number: NCT01768416

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

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.

Completed

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Key information

Conditions

Loss of Consciousness at End of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: BISSOPS

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 15, 2013
Registry last updated: Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.