Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT02281903
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Resuscitation With Feedback CPR Devices
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-15', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions', 'timeFrame': '1 month', 'description': 'effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions'}], 'secondaryOutcomes': [{'measure': 'effective compressions ratio effective compressions [%] multiplied by flow time [%]', 'timeFrame': '1 month', 'description': 'effective compressions ratio was defined as effective compressions \\[%\\] multiplied by flow time \\[%\\]'}, {'measure': 'Flow time sum of all periods during which chest compressions were performed.', 'timeFrame': '1 month', 'description': 'flow time was defined as the sum of all periods during which chest compressions were performed.'}, {'measure': 'absolute hands-off time sum of all periods without chest compressions or ventilation', 'timeFrame': '1 month', 'description': 'absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation'}, {'measure': 'Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer', 'timeFrame': '1 month', 'description': 'compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.', 'detailedDescription': 'Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* give voluntary consent to participate in the study\n* medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT02281903', 'acronym': 'PRFD', 'briefTitle': 'Pediatric Resuscitation With Feedback CPR Devices', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study', 'orgStudyIdInfo': {'id': 'CPR/2014/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chest compression of manikins chest', 'description': 'Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.', 'interventionNames': ['Device: The TrueCPR feedback device', 'Device: Standard BLS']}], 'interventions': [{'name': 'The TrueCPR feedback device', 'type': 'DEVICE', 'description': 'feedback devices', 'armGroupLabels': ['Chest compression of manikins chest']}, {'name': 'Standard BLS', 'type': 'DEVICE', 'description': 'Standard basic life support = chest compressions without any feedback device (manual resuscitation)', 'armGroupLabels': ['Chest compression of manikins chest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-122', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Lukasz Szarpak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Institute of Rescue Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lukasz Szarpak', 'investigatorFullName': 'Lukasz Szarpak', 'investigatorAffiliation': 'National Institute of Cardiology, Warsaw, Poland'}}}}