Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-21 @ 6:33 AM
Study NCT ID:
NCT02000505
Status:
UNKNOWN
Last Update Posted:
2015-05-05
First Post:
2013-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback 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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-02', 'studyFirstSubmitDate': '2013-11-17', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average achieved cardiac output', 'timeFrame': 'after 5 minutes', 'description': 'The main goal of the study is the average achieved cardiac output. Data acquisition is carried out on a resuscitation-manikin which can measure compression-rate (CR) and compression-depth (CD). The data are recorded by a computer during the CPR. To calculate the cardiac output, we multiply the average CR \\[1/min\\] with the average CD \\[mm\\] during the 5 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in \\[mm/min\\], will be compared in each group.'}], 'secondaryOutcomes': [{'measure': 'Constancy of the quality of chest-compressions', 'timeFrame': 'after 5 minutes', 'description': 'Second objective of the study is the variation of the compression-rate and the compression-depth during the resuscitation. We compare the average compression-rate and compression-depth of the first 30 compressions and the last 30 compression of every participant. As a result, the average standard deviation in each group will be calculated. Afterward, the groups will be compared using the mean deviation of every group. The mean deviation will be measured in +/-\\[mm\\] for compression-depth and +/-\\[1/min\\] for compression rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Comparison of various methods to improve the quality of CPR', 'detailedDescription': 'Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even among professional helpers. This is especially due to some very different mean frequencies of cardiac compression wich vary from 60 to 160/min for paramedics. Aim of this study is to investigate whether the use of feedback-devices during cardiac-pulmonary resuscitation (CPR) can lead to an improvement of the cardiac output and may improve survival.\n\nFor this, we examine the impact of different feedback-methods on the frequence-variety on manikin by lay rescuers. Overall, we compare three different devices for feedback during CPR. The subjects for this study are lay rescuers who perform a 5 minute chest-compression-only CPR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lay rescuers\n* \\>18 years\n* \\<60 years\n\nExclusion Criteria:\n\n* professional rescuers\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02000505', 'acronym': 'frequenz', 'briefTitle': 'Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': 'Comparison of the Quality of CPR by Lay Rescuers With and Without Telephone Instructions by a Simulated Rescue Coordination Center', 'orgStudyIdInfo': {'id': '10-333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '5 minutes chest-compression-only CPR, without any support'}, {'type': 'EXPERIMENTAL', 'label': 'PocketCPR', 'description': '5 minutes chest-compression-only CPR, with support', 'interventionNames': ['Device: PocketCPR']}, {'type': 'EXPERIMENTAL', 'label': 'Metronome', 'description': '5 minutes chest-compression-only CPR, with support', 'interventionNames': ['Device: Metronome']}, {'type': 'EXPERIMENTAL', 'label': '110bpm Song', 'description': '5 minutes chest-compression-only CPR, with support', 'interventionNames': ['Device: 110bpm Song']}], 'interventions': [{'name': 'PocketCPR', 'type': 'DEVICE', 'description': '5 minutes chest-compression-only CPR, using Zoll PocketCPR', 'armGroupLabels': ['PocketCPR']}, {'name': 'Metronome', 'type': 'DEVICE', 'description': '5 minutes chest-compression-only CPR, using a metronome', 'armGroupLabels': ['Metronome']}, {'name': '110bpm Song', 'type': 'DEVICE', 'description': '5 minutes chest-compression-only CPR, using a song with 110bpm for support', 'armGroupLabels': ['110bpm Song']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Braunecker, MD', 'role': 'CONTACT', 'email': 'stefan.braunecker@uk-koeln.de', 'phone': '0221-478-97729'}, {'name': 'Stefan Braunecker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jochen Hinkelbein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Stefan Braunecker, MD', 'role': 'CONTACT', 'email': 'stefan.braunecker@uk-koeln.de'}], 'overallOfficials': [{'name': 'Stefan Braunecker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Cologne'}, {'name': 'Jochen Hinkelbein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist, Researcher', 'investigatorFullName': 'Dr. med. Stefan Braunecker', 'investigatorAffiliation': 'University Hospital of Cologne'}}}}