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

NCT ID: NCT03368326

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-09

Study Completion Date

2017-10-10

Brief Summary

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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

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Conditions

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Intensive Care Brain Injuries

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bispectral Index (BIS)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Xin Zhou

Director of Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

Locations

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Intensive care unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CHDR-2014-2-2041

Identifier Type: -

Identifier Source: org_study_id