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

NCT03368326 | Completed DMC

• 1 other identifier: CHDR-2014-2-2041
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care; Brain Injuries

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Interventions

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.

Also known as: Bispectral Index (BIS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with brain injury and artificial airway

You may qualify if:

• patients with brain injury and artificial airway

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jian-Xin Zhou, MD

  Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 11, 2017
• Study Start: June 9, 2015
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

CN (1)