Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-09 @ 9:50 AM
Study NCT ID:
NCT03140202
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2017-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS)
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In Guide group, participants have a real time feedback (and record) on chest compression quality performed by means of the visuals informations profided by the feedback device.\n\nIn Blind group, participants have a real time record of chest compression quality performed by means of the feedback device without feedback information of the performance.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamic effect n1 of Cardiopulmonary Resuscitation', 'timeFrame': 'Day 0', 'description': 'Impact of Cardiopulmonary Resuscitation effort on participant blood pressure (mmHg)'}, {'measure': 'Hemodynamic effect n2 of Cardiopulmonary Resuscitation', 'timeFrame': 'Day 0', 'description': 'Impact of Cardiopulmonary Resuscitation effort on participant heart frequency (/min)'}], 'primaryOutcomes': [{'measure': 'Correct compression score', 'timeFrame': 'Day 0', 'description': 'Correct compression score is defined by reached target of rate (between 100/min and 120/min), depth (between 50 mm and 60 mm) and leaning (less than 2500g) at the same time'}], 'secondaryOutcomes': [{'measure': 'Decrease time of 30% of correct compression score', 'timeFrame': 'Day 0', 'description': 'Time at witch correct compression score decrease of 30% of the reference correct compression score (first 20 secondes)'}, {'measure': 'Chest compression depth', 'timeFrame': 'Day 0', 'description': 'Chest compression depth reached (in mm)'}, {'measure': 'Chest compression rate', 'timeFrame': 'Day 0', 'description': 'Chest compression rate per min'}, {'measure': 'Percentage of chest compression without leaning', 'timeFrame': 'Day 0', 'description': 'Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g'}, {'measure': 'Percentage of chest compression with correct depth', 'timeFrame': 'Day 0', 'description': 'Percentage of chest compression with depth between 50 mm and 60 mm'}, {'measure': 'Percentage of correct chest compression rate', 'timeFrame': 'Day 0', 'description': 'Percentage chest compression rate between 100/min and 120/min'}, {'measure': "Participants' fatigue (Borg's scale)", 'timeFrame': 'Day 0', 'description': 'Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Context: Chest compressions quality is known to be essential in cardiopulmonary resuscitation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed.\n\nStudy design: simulated prospective monocentric randomized crossover trial.\n\nParticipants and methods: Sixty five professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 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 preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operational staff of University hospital of Caen pre-hospital unit\n* Ability in CardioPulmonary Resuscitation\n\nExclusion Criteria:\n\n* medical contraindication\n* refusal'}, 'identificationModule': {'nctId': 'NCT03140202', 'acronym': 'CILICA-QS', 'briefTitle': 'Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality Preservation During Cardio-pulmonary Resuscitation: A Manikin Study', 'orgStudyIdInfo': {'id': 'A16-D51-VOL.30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guide then blind', 'description': 'This group use the CPRmeter visual feedback during cardiopulmonary resuscitation (screen visible) first, then have no access to the CPRmeter visual feedback during cardiopulmonary resuscitation (screen mask).', 'interventionNames': ['Device: CPRmeter (feedback device) with feedback', 'Device: CPRmeter (feedback device) without feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Blind then guide', 'description': 'This group have no access to the CPRmeter visual feedback during cardiopulmonary resuscitation (screen mask) first then use the CPRmeter visual feedback during cardiopulmonary resuscitation (screen visible).', 'interventionNames': ['Device: CPRmeter (feedback device) with feedback', 'Device: CPRmeter (feedback device) without feedback']}], 'interventions': [{'name': 'CPRmeter (feedback device) with feedback', 'type': 'DEVICE', 'description': 'Participants have a real time feedback and record.', 'armGroupLabels': ['Blind then guide', 'Guide then blind']}, {'name': 'CPRmeter (feedback device) without feedback', 'type': 'DEVICE', 'description': 'Participants have a real time record without feedback.', 'armGroupLabels': ['Blind then guide', 'Guide then blind']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Normandy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clement BULEON, MD', 'role': 'CONTACT', 'email': 'buleon-c@chu-caen.fr', 'phone': '+(33)231064736'}, {'name': 'Christophe PERSYN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tiphaine BRY', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laurent HALBOUT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier ARROT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne-Laure LEPORI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Clement BULEON, MD', 'role': 'CONTACT', 'email': 'buleon-c@chu-caen.fr', 'phone': '+(33)231064736'}], 'overallOfficials': [{'name': 'Clement BULEON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Simulation Center Normandie Simulation en Sante'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}