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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368326
• Other study ID #: CHDR-2014-2-2041
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 7, 2017
• Start date: June 9, 2015
• Est. completion date: October 10, 2017

Study information

• Verified date: December 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Intensive Care
• Pain

Intervention

Diagnostic Test:
• Critical-Care Pain Observation Tool (CPOT)
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.

Locations

Country	Name	City	State
China	Intensive care unit, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of the Critical-Care Pain Observation Tool (CPOT) scores	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.	1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.
Primary	Changes of the bispectral Index (BIS) value	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).	1.Before nociceptive/non-nociceptive procedure; 2.Within the first 5 minutes after nociceptive/non-nociceptive procedure.