Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT02283034
Status:
UNKNOWN
Last Update Posted:
2014-11-05
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Pediatric Resuscitation
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-02', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-11-02', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective compressions was defined as 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': 'Chest compression depth', 'timeFrame': '1 month', 'description': 'To measure chest compression depth during 8 minutes. Chest compression depth will be measured using the software connected to the manikin and computer'}, {'measure': 'Chest compression rate', 'timeFrame': '1 month', 'description': 'To measure the chest compression rate during 8 minutes. Chest compression rate will be measured using the software connected to the manikin and computer'}, {'measure': 'effective compressions ratio was defined as 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 was defined as the 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 was defined as the 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': 'VAS (visual analogue scale)', 'timeFrame': '1 month', 'description': 'after having completed the 8 min testing period, the study participants were asked how challenging they had experienced standard BLS or resuscitation which the respective feedback device. answers were rated on a 10-point Lickert scale (most difficult = 1 to easiest = 10)'}, {'measure': 'Prefered CPR device', 'timeFrame': '1 month', 'description': 'after having completed the 8 min testing period, the study participants were asked how chellenging whitch method they would preferred. answers were rated on a 10-point Lickert scale (lower preferred = 1 to most preferred = 10)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare five CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between 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': 'NCT02283034', 'acronym': 'EPR', 'briefTitle': 'Effectiveness of Pediatric Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Quality of Chest Compressions During 8 Min of Single-rescuer Pediatric Cardiopulmonary Resuscitation With Five Different CPR Feedback Devices. Randomised Crossover Manikin Trial', 'orgStudyIdInfo': {'id': 'CPR/2014/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With feedback', 'description': 'Participants compress the chest of the manikin with CPR feedback device.', 'interventionNames': ['Device: Standard BLS']}, {'type': 'EXPERIMENTAL', 'label': 'Without feedback', 'description': 'Participants compress the chest of the manikin without CPR feedback device', 'interventionNames': ['Device: The CPRmeter', 'Device: The PocketCPR', 'Device: Standard BLS', 'Device: The CPREazy', 'Device: The CPR PRO APP', 'Device: The CardioPump']}], 'interventions': [{'name': 'The CPRmeter', 'type': 'DEVICE', 'description': 'Feedback device - 1', 'armGroupLabels': ['Without feedback']}, {'name': 'The PocketCPR', 'type': 'DEVICE', 'description': 'Feedback device - 2', 'armGroupLabels': ['Without feedback']}, {'name': 'Standard BLS', 'type': 'DEVICE', 'description': 'Standard basic life support = chest compressions without any feedback device (manual resuscitation)', 'armGroupLabels': ['Without feedback']}, {'name': 'The CPREazy', 'type': 'DEVICE', 'description': 'Feedback device - 3', 'armGroupLabels': ['Without feedback']}, {'name': 'The CPR PRO APP', 'type': 'DEVICE', 'description': 'Feedback device - 4', 'armGroupLabels': ['Without feedback']}, {'name': 'The CardioPump', 'type': 'DEVICE', 'description': 'Feedback devices - 5', 'armGroupLabels': ['Without feedback']}, {'name': 'Standard BLS', 'type': 'DEVICE', 'description': 'Chest compressions without CPR feedback device (manual resuscitation)', 'armGroupLabels': ['With feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-122', 'city': 'Warsaw', 'state': 'Masovia', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lukasz Szarpak', 'role': 'CONTACT', 'email': 'lukasz.szarpak@gmail.com', 'phone': '+48500186225'}], 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Lukasz Szarpak', 'role': 'CONTACT', 'email': 'lukasz.szarpak@gmail.com', 'phone': '+48500186225'}], 'overallOfficials': [{'name': 'Andrzej Kurowski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Cardiology'}, {'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'}}}}