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

Study Overview
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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).

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

Conditions
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Intubated Brain Injured

Intervention / Treatment
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* Other: NCS-I (Nociception Coma Scale adapted intubated patients)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion (30 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Through study completion (30 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients, Intensive care unit, Neuro-ICU, Pain, Intubation, critical care