Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-04-22 @ 8:50 AM
Study NCT ID:
NCT02322359
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2014-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Is Life In Cardiac Arrest - Fatigue Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct compression score', 'timeFrame': '24h', 'description': 'Correct compression score is defined by reached target of rate, depth and leaning at the same time'}], 'secondaryOutcomes': [{'measure': 'Decrease time of 30% of correct compression score', 'timeFrame': '24h'}, {'measure': 'chest compression deep', 'timeFrame': '24h'}, {'measure': 'chest compression rate', 'timeFrame': '24h'}, {'measure': 'percentage of chest compression without leaning', 'timeFrame': '24h'}, {'measure': 'percentage of chest compression with correct deep', 'timeFrame': '24h'}, {'measure': 'percentage of correct chest compression rate', 'timeFrame': '24h'}, {'measure': "participants' fatigue (Borg's scale)", 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed.\n\nStudy design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).\n\nHypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers from University hospital of Caen pre-hospital unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operational staff of University hospital of Caen pre-hospital unit\n\nExclusion Criteria:\n\n* medical contraindication\n* refusal'}, 'identificationModule': {'nctId': 'NCT02322359', 'acronym': 'CILICA-FS', 'briefTitle': 'Compression Is Life In Cardiac Arrest - Fatigue Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.', 'orgStudyIdInfo': {'id': 'A14-D20-VOL.21'}}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'University Hospital of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Clement BULEON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}