Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-22 @ 5:30 AM
Study NCT ID:
NCT05454202
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of the ANI between before the care and during the care', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}], 'secondaryOutcomes': [{'measure': 'Variation of the ANI between during the care and after the care', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}, {'measure': 'Coefficient of correlation between the variation of the ANI and the variation of the CPOT scale between each periods.', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}, {'measure': 'Coefficient of correlation between the minANI and the CPOT scale for each periods', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}, {'measure': 'Coefficient of correlations between ANImin and CPOT values before, during, and after the painful care session', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}, {'measure': 'The discriminatory power of the ANI to separate the non-comfortable and the comfortable population defined by a ≤ 2 threshold on the CPOT scale', 'timeFrame': 'From 10 minutes before the care to 10 minutes after the care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia/Nociception Index', 'end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating', 'comfort evaluation', 'comfort monitoring', 'palliative care', 'non-communicating'], 'conditions': ['End of Life', 'Pain', 'Analgesia']}, 'descriptionModule': {'briefSummary': "Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety.\n\nSo, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients.\n\nThat is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-communicating end-of-life patient hospitalized in palliative care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)\n\nExclusion Criteria:\n\n* Non sinusal heart rate\n* Respiratory rate \\< 9/min\n* Treated by inotropes\n* Pace-maker\n* Patient in agonal phase\n* Opposition from the guardian'}, 'identificationModule': {'nctId': 'NCT05454202', 'acronym': 'ANI-CARE', 'briefTitle': 'Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care', 'orgStudyIdInfo': {'id': '2021_0830'}, 'secondaryIdInfos': [{'id': '2022-A00631-42', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-communicating', 'description': 'Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old)', 'interventionNames': ['Device: ANI']}], 'interventions': [{'name': 'ANI', 'type': 'DEVICE', 'description': 'Pain measurement during care procedures in palliative care', 'armGroupLabels': ['Non-communicating']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hop Cardiologique Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Chloe PRODHOMME, MD', 'role': 'CONTACT', 'email': 'chloe.prodhomme@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Chloe PRODHOMME, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}