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

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ClinicalTrials.gov Identifier: NCT02830256
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Intubated Brain Injured Other: NCS-I (Nociception Coma Scale adapted intubated patients)

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).

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care


Intervention Details:
  • 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).


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Admission to intensive care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830256


Locations
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France
UHMontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02830256    
Other Study ID Numbers: 9673
2016-A00748-43 ( Other Identifier: RCB number )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
Intensive care unit
Neuro-ICU
Pain
Intubation
critical care
patients