Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

NCT ID: NCT02830256

Last Updated: 2018-12-05

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-03

Study Completion Date

2017-11-28

Brief Summary

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Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Detailed Description

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Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Conditions

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Intubated Brain Injured

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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NCS-I (Nociception Coma Scale adapted intubated patients)

Every included patient will be assessed by the 3 methods 3 times (before, during, after the procedure fo care) in 3 conditions. There will be 2 painful conditions usually performed in ICU (Nursing and bronchoaspiration) and a painless condition (RASS assessment).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult, \> or equal to 18-yr
* Admission to intensive care unit
* Brain injured and intubated patient
* Signs of awakening after the interruption of sedation
* Impossibility to self-report pain intensity

Exclusion Criteria

* Eye injuries (glaucoma, keratitis, conjunctivis, cataract)
* Neurodegenerative attack
* Brainstem damage
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GERALD CHANQUES, MD PH D

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Pierre François PERRIGAULT, MD

Role: STUDY_CHAIR

University Hospital, Montpellier

Christine BERNARD, CRNA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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UHMontpellier

Montpellier, , France

Site Status

Countries

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France

References

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Bernard C, Delmas V, Duflos C, Molinari N, Garnier O, Chalard K, Jaber S, Perrigault PF, Chanques G. Assessing pain in critically ill brain-injured patients: a psychometric comparison of 3 pain scales and videopupillometry. Pain. 2019 Nov;160(11):2535-2543. doi: 10.1097/j.pain.0000000000001637.

Reference Type DERIVED
PMID: 31188267 (View on PubMed)

Other Identifiers

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2016-A00748-43

Identifier Type: OTHER

Identifier Source: secondary_id

9673

Identifier Type: -

Identifier Source: org_study_id

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