Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients (D co réa)

December 4, 2018 updated by: University Hospital, Montpellier
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Admission to intensive care unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight kappa coefficient for pain using the NCS-I
Time Frame: 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).
Through study completion (30 months)
Weight kappa coefficient for pain using the BPS
Time Frame: 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).
Through study completion (30 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: GERALD CHANQUES, MD PH D, University Hospital, Montpellier
  • Study Chair: Pierre François PERRIGAULT, MD, University Hospital, Montpellier
  • Principal Investigator: Christine BERNARD, CRNA, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2016

Primary Completion (ACTUAL)

November 28, 2017

Study Completion (ACTUAL)

November 28, 2017

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9673 (Other Identifier: CTEP)
  • 2016-A00748-43 (OTHER: RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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