Clinical trial NCT02830256: Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients
Official title: Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubated Brain Injured
Keywords: Intensive care unit
Neuro-ICU
Pain
Intubation
critical care
patients
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admission to intensive care unit

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Difference in pain scores or pupillary diameter measures at rest and during care procedures
timeFrame: Through study completion (30 months)
Secondary outcomes:
measure: Weight kappa coefficient for pain using the NCS-I
timeFrame: Through study completion (30 months)
measure: Weight kappa coefficient for pain using the BPS
timeFrame: Through study completion (30 months)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHMontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: GERALD CHANQUES, MD PH D
role: STUDY_DIRECTOR
affiliation: University Hospital, Montpellier
name: Pierre François PERRIGAULT, MD
role: STUDY_CHAIR
affiliation: University Hospital, Montpellier
name: Christine BERNARD, CRNA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.