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

Completed

• Conditions: Intubated Brain Injured

• Registration Number: NCT02830256
• Lead Sponsor: University Hospital, Montpellier

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).

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-11-03
• Status Verified: 2017-04
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in pain scores or pupillary diameter measures at rest and during care procedures	Through study completion (30 months)	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.

Secondary Outcome Measures

Name	Time	Method
Weight kappa coefficient for pain using the NCS-I	Through study completion (30 months)	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).
Weight kappa coefficient for pain using the BPS	Through study completion (30 months)	Weighted kappa coefficient will be used to measure inter-observers agreement using the two subjective pain scales (NCS-I and BPS).

Trial Locations

Locations (1)

UHMontpellier; 🇫🇷 Montpellier, France