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

Completed

• Conditions: Intensive Care; Brain Injuries

• Registration Number: NCT03368326
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-09
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of the Critical-Care Pain Observation Tool (CPOT) scores	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	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).

Trial Locations

Locations (1)

Intensive care unit, Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China