Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients

Brain injured patients are at high risk of pain due to the illness itself and a variety of nociceptive procedures in intensive care unit. Since the disorder of consciousness, speech, and movement, it is usually difficult for them to self-report the presence of pain reliably. The Critical-Care Pain observation Tool (CPOT) has been recommended for clinical use in the critically ill patients when self-report pain is unavailable. Besides, it seems that the bispectral index (BIS), a quantified electroencephalogram instrument, can be used for pain assessment along with the CPOT tool in some nonverbal critical ill patients (e.g., intubated and deep sedation). However, the validity and reliability of CPOT and BIS for pain assessment in brain injured patients are still uncertain so far. So the aim of this research is to investigate the value of CPOT and BIS for pain evaluation in this specific patient group.

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Key information

Conditions

Intensive Care Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients with brain injury and artificial airway

Exclusion criteria

age under 18 years,
quadriplegia,
administration of paralytic medications within 24 hours,
if the patient failed the quality test of BIS signal,
impending death,
be included in any other research.

Treatment and study plan

Critical-Care Pain Observation Tool (CPOT)

Diagnostic Test

The CPOT includes 4 behaviors: (1) facial expression, (2) body movements, (3) compliance with the ventilator, and (4) muscle tension. Each behavior is rated from 0 to 2 for a possible total score ranging from 0 to 8.

Other names: Bispectral Index (BIS)

Primary outcomes

Changes of the Critical-Care Pain Observation Tool (CPOT) scores

Time frame: 1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.

The CPOT includes 4 behaviors: (1) facial expression, (2) body movements, (3) compliance with the ventilator, and (4) muscle tension. Each behavior is rated from 0 to 2 for a possible total score ranging from 0 to 8.
Changes of the bispectral Index (BIS) value

Time frame: 1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.

The BIS monitor is a noninvasive technology, which measures different electrocortical indices through electrodes placed on the patient's forehead. Its main variable, the BIS index, consists of a single number computed from a complex algorithmic equation based on the EEG data. Its value can range from 0 (complete EEG suppression) to 100 (fully awake).

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients：A Prospective Observational Study

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Dec 11, 2017
Registry last updated: Dec 11, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed