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

University Hospital, Montpellier50 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intubated Brain Injured

Interventions

NCS-I (Nociception Coma Scale adapted intubated patients)OTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

UHMontpellier

Montpellier, France

Outcomes

Primary Outcomes

Difference in pain scores or pupillary diameter measures at rest and during care procedures

Discriminant validity between NCS-I, BPS and pupillary measurements will follow current recommended method for psychometric assessment of pain tools in critical care patients (Pain Agitation and Delirium Guidelines from the Society of Critical Care Medicine, Barr et al. Crit Care Med 2013). Mann-Whitney-Wilcoxon test will be used to compare values obtained at rest and during the procedures of care.

Time frame: Through study completion (30 months)

Secondary Outcomes

Weight kappa coefficient for pain using the NCS-I

Reliability of NCS-I and BPS will follow current recommended method for psychometric assessment of pain tools in critical care patients (Pain Agitation and Delirium Guidelines from the Society of Critical Care Medicine, Barr et al. Crit Care Med 2013).

Time frame: Through study completion (30 months)

Weight kappa coefficient for pain using the BPS

Weighted kappa coefficient will be used to measure inter-observers agreement using the two subjective pain scales (NCS-I and BPS).

Time frame: Through study completion (30 months)

Data from ClinicalTrials.gov

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