Skip to main content
Clinical Trials/NCT02830256
NCT02830256
Completed
N/A

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

University Hospital, Montpellier1 site in 1 country50 target enrollmentNovember 3, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intubated Brain Injured
Sponsor
University Hospital, Montpellier
Enrollment
50
Locations
1
Primary Endpoint
Difference in pain scores or pupillary diameter measures at rest and during care procedures
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 3, 2016
End Date
November 28, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Weight kappa coefficient for pain using the NCS-I(Through study completion (30 months))
  • Weight kappa coefficient for pain using the BPS(Through study completion (30 months))

Study Sites (1)

Loading locations...

Similar Trials