Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 2:30 PM
Study NCT ID:
NCT05639868
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Video-assisted Cardiopulmonary 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of chest compressions (depth of chest compressions).', 'timeFrame': 'During procedure', 'description': 'Chest compression depth will be evaluated by a manikin connected to a CPR software.'}, {'measure': 'Quality of chest compressions (rate of chest compressions).', 'timeFrame': 'During procedure', 'description': 'Chest compression rate will be evaluated by a manikin connected to a CPR software.'}, {'measure': 'Quality of chest compressions (hand position of chest compressions).', 'timeFrame': 'During procedure', 'description': 'Hand position during chest compression will be evaluated by observation.'}], 'secondaryOutcomes': [{'measure': 'Time factors of CPR', 'timeFrame': 'During procedure', 'description': 'Measuring the time of check breathing, time to recognize cardiac arrest, time to first chest compression, and cumulative time of no-flow time by the CPR software and observation.'}, {'measure': 'Attitude of bystanders.', 'timeFrame': 'Immediately after the CPR procedure (within 15 minutes)', 'description': 'Subjective feelings after performing CPR based on a short survey using Likert-scale based queries (lower numbers indicate worse, higher score indicates better opinion).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '37696968', 'type': 'DERIVED', 'citation': 'Szollosi V, Horvath B, Nemeth D, Banfai-Csonka H, Betlehem J, Banfai B. A randomized controlled simulation trial comparing video-assisted with telephone-assisted and unassisted cardiopulmonary resuscitation performed by non-healthcare university students. Sci Rep. 2023 Sep 11;13(1):14925. doi: 10.1038/s41598-023-42131-z.'}]}, 'descriptionModule': {'briefSummary': 'Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. Emergency Medical Services (EMS) dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.\n\nEffectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (effectiveness of chest compression, time parameters eg. time to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.', 'detailedDescription': 'Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. EMS dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.\n\nEffectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (quality of chest compressions: depth, rate, hand position), time parameters: time to recognize cardiac arrest, time of check breathing, total no-flow time, to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer\n\nExclusion Criteria:\n\n* healthcare professionals (paramedics, nurses, etc.)\n* pregnant women\n* people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 2 minutes\n* psychological disabilities'}, 'identificationModule': {'nctId': 'NCT05639868', 'briefTitle': 'Effectiveness of Video-assisted Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Is Video-assisted Cardiopulmonary Resuscitation More Effective Than Telephone-assisted or Not-instructed Cardiopulmonary Resuscitation by Laypeople? - a Randomized Controlled Simulation Study', 'orgStudyIdInfo': {'id': 'Upecs_V-CPR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T-CPR', 'description': 'Participants perform telephone-assisted CPR based on the European Resuscitation Council (ERC) 2021 guidelines.', 'interventionNames': ['Other: Video-assisted CPR', 'Other: Telephone-assisted CPR']}, {'type': 'EXPERIMENTAL', 'label': 'V-CPR', 'description': 'Participants perform video-assisted CPR based on the European Resuscitation Council (ERC) 2021 guidelines.', 'interventionNames': ['Other: Video-assisted CPR', 'Other: Telephone-assisted CPR']}, {'type': 'NO_INTERVENTION', 'label': 'Unassisted CPR', 'description': 'CPR without dispatcher instructions.'}], 'interventions': [{'name': 'Video-assisted CPR', 'type': 'OTHER', 'description': 'Participants in V-CPR group get video-based (vocal and visual) instructions from the dispatcher.', 'armGroupLabels': ['T-CPR', 'V-CPR']}, {'name': 'Telephone-assisted CPR', 'type': 'OTHER', 'description': 'Participants in T-CPR group get voice-based (vocal) instructions from the dispatcher.', 'armGroupLabels': ['T-CPR', 'V-CPR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7621', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}], 'overallOfficials': [{'name': 'Bálint Bánfai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pecs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior lecturer', 'investigatorFullName': 'Dr. Bálint Bánfai', 'investigatorAffiliation': 'University of Pecs'}}}}