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

Sponsor
Capital Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03368326
Collaborator
(none)
400
1
28.1
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Critical-Care Pain Observation Tool (CPOT)

Study Design

Study Type:
Observational
Actual Enrollment :
400 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients:A Prospective Observational Study
Actual Study Start Date :
Jun 9, 2015
Actual Primary Completion Date :
Oct 10, 2017
Actual Study Completion Date :
Oct 10, 2017

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intensive care unit, Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100050

Sponsors and Collaborators

  • Capital Medical University

Investigators

  • Principal Investigator: Jian-Xin Zhou, MD, Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jian-Xin Zhou, Director of Intensive Care Unit, Capital Medical University
ClinicalTrials.gov Identifier:
NCT03368326
Other Study ID Numbers:
  • CHDR-2014-2-2041
First Posted:
Dec 11, 2017
Last Update Posted:
Dec 11, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 11, 2017