Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02830256
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2016-06-13', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in pain scores or pupillary diameter measures at rest and during care procedures', 'timeFrame': 'Through study completion (30 months)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Weight kappa coefficient for pain using the NCS-I', 'timeFrame': 'Through study completion (30 months)', 'description': '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).'}, {'measure': 'Weight kappa coefficient for pain using the BPS', 'timeFrame': 'Through study completion (30 months)', 'description': 'Weighted kappa coefficient will be used to measure inter-observers agreement using the two subjective pain scales (NCS-I and BPS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intensive care unit', 'Neuro-ICU', 'Pain', 'Intubation', 'critical care', 'patients'], 'conditions': ['Intubated Brain Injured']}, 'referencesModule': {'references': [{'pmid': '31188267', 'type': 'DERIVED', 'citation': 'Bernard C, Delmas V, Duflos C, Molinari N, Garnier O, Chalard K, Jaber S, Perrigault PF, Chanques G. Assessing pain in critically ill brain-injured patients: a psychometric comparison of 3 pain scales and videopupillometry. Pain. 2019 Nov;160(11):2535-2543. doi: 10.1097/j.pain.0000000000001637.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Admission to intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult, \\> or equal to 18-yr\n* Admission to intensive care unit\n* Brain injured and intubated patient\n* Signs of awakening after the interruption of sedation\n* Impossibility to self-report pain intensity\n\nExclusion criteria:\n\n* Eye injuries (glaucoma, keratitis, conjunctivis, cataract)\n* Neurodegenerative attack\n* Brainstem damage\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02830256', 'acronym': 'D co réa', 'briefTitle': 'Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients', 'orgStudyIdInfo': {'id': '9673'}, 'secondaryIdInfos': [{'id': '2016-A00748-43', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'NCS-I (Nociception Coma Scale adapted intubated patients)', 'type': 'OTHER', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UHMontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'GERALD CHANQUES, MD PH D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Pierre François PERRIGAULT, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Christine BERNARD, CRNA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}