Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 12:49 AM
Study NCT ID:
NCT00449969
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2007-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback
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': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-21', 'studyFirstSubmitDate': '2007-03-20', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratio of patients with spontaneous circulation', 'timeFrame': 'admission to the hospital'}], 'secondaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': 'hospital discharge'}, {'measure': 'neurological status', 'timeFrame': 'hospital discharge'}, {'measure': 'neurological status', 'timeFrame': 'one year after resuscitation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AED (automated external defibrillation)', 'feedback', 'out of hospital resuscitation'], 'conditions': ['Cardiac Arrest', 'Resuscitation']}, 'referencesModule': {'references': [{'pmid': '20151103', 'type': 'RESULT', 'citation': 'Lukas RP, Sengelhoff C, Dopker S, Harding U, Mertens P, Osada N, Van Aken H, Weber TP, Bohn A. [Chest compression quality : Can feedback technology help?]. Anaesthesist. 2010 Feb;59(2):135-9. doi: 10.1007/s00101-009-1671-4. German.'}, {'pmid': '21146279', 'type': 'RESULT', 'citation': 'Bohn A, Weber TP, Wecker S, Harding U, Osada N, Van Aken H, Lukas RP. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation. 2011 Mar;82(3):257-62. doi: 10.1016/j.resuscitation.2010.11.006. Epub 2010 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an online automatic feedback improved CPR quality (No-flow time, compression depth, short-term survival and one year follow up) in this prospective randomised study of out-of-hospital cardiac arrest'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac arrest\n\nExclusion Criteria:\n\n* age under 18 years'}, 'identificationModule': {'nctId': 'NCT00449969', 'briefTitle': 'Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Quality of Out-of-hospital Cardiopulmonary Resuscitation (CPR) With Real Time Automated Feedback: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '02-AnIt-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Extended feedback', 'interventionNames': ['Device: Zoll AED pro']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Limited feedback', 'interventionNames': ['Device: Zoll AED pro']}], 'interventions': [{'name': 'Zoll AED pro', 'type': 'DEVICE', 'description': 'Arm one (Extended feedback) offers full feedback guidance during CPR', 'armGroupLabels': ['1. Extended feedback']}, {'name': 'Zoll AED pro', 'type': 'DEVICE', 'description': 'In arm two (limited feedback) feedback is modified lacking several elements of feedback', 'armGroupLabels': ['2. Limited feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care, University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Thomas P Weber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Intensive Care, University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thomas P. Weber, principle investigator', 'oldOrganization': 'Department of Anesthesiology and Intensive Care'}}}}