Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 2:38 AM
Study NCT ID:
NCT02703103
Status:
UNKNOWN
Last Update Posted:
2016-04-06
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Compression During Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chest compressions effectiveness', 'timeFrame': '1 day', 'description': 'the percentage of correct chest compressions relative to the total number of chest compressions'}], 'secondaryOutcomes': [{'measure': 'Depth', 'timeFrame': '1 day', 'description': 'correct depth according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation'}, {'measure': 'Pressure point', 'timeFrame': '1 day', 'description': 'correct pressure point according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation'}, {'measure': 'Complete pressure release', 'timeFrame': '1 day', 'description': 'Complete pressure release measure by manikin software'}, {'measure': 'Rate of chest compressions', 'timeFrame': '1 day', 'description': 'correct chest compressions rate according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation'}, {'measure': 'hands-off time', 'timeFrame': '1 day', 'description': 'defined as the sum of all periods during which no hand was placed on the chest minus time used for ventilation.'}, {'measure': 'tidal volume', 'timeFrame': '1 day', 'description': 'volume of air delivered in a single rescue breath in milliliters'}, {'measure': 'ventilation rate', 'timeFrame': '1 day', 'description': 'respiratory rate per minute'}, {'measure': 'minute-volume', 'timeFrame': '1 day', 'description': 'minute volume ventilation'}, {'measure': 'number of gastric inflations', 'timeFrame': '1 day', 'description': 'number of gastric inflations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiopulmonary resuscitation', 'chest compression', 'adult', 'simulation'], 'conditions': ['Cardiopulmonary Resuscitation']}, 'referencesModule': {'references': [{'pmid': '26612703', 'type': 'BACKGROUND', 'citation': 'Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.'}, {'pmid': '25455057', 'type': 'BACKGROUND', 'citation': 'Kurowski A, Czyzewski L, Bogdanski L, Zasko P, Karczewska K, Szarpak L. Quality of chest compression with CardioPump CPR compared to single rescuer standard BLS. Am J Emerg Med. 2015 Jan;33(1):114-5. doi: 10.1016/j.ajem.2014.10.027. Epub 2014 Oct 20. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.'}, '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* maximum 1 year of work experience in medicine\n* minimum 10 clinical resuscitations\n* paramedics\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02703103', 'briefTitle': 'Chest Compression During Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Use of a New Mechanical Chest Compression Machine LifeLine ARM for Cardiopulmonary Resuscitation by Paramedics: a Randomized, Crossover, Manikin Trial', 'orgStudyIdInfo': {'id': '02.008.1MR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard cardiopulmonary resuscitation', 'description': 'standard CPR (30:2) according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.', 'interventionNames': ['Other: Manual chest compressions', 'Device: ARM chest compressions']}, {'type': 'EXPERIMENTAL', 'label': 'asynchronous cardiopulmonary resuscitation', 'description': 'asynchronuos CPR according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.', 'interventionNames': ['Other: Manual chest compressions', 'Device: ARM chest compressions']}], 'interventions': [{'name': 'Manual chest compressions', 'type': 'OTHER', 'description': '2 min of Chest compressions without mechanical chest compression system', 'armGroupLabels': ['Standard cardiopulmonary resuscitation', 'asynchronous cardiopulmonary resuscitation']}, {'name': 'ARM chest compressions', 'type': 'DEVICE', 'description': '2 min of Chest compressions with mechanical chest compression system LifeLine ARM', 'armGroupLabels': ['Standard cardiopulmonary resuscitation', 'asynchronous cardiopulmonary resuscitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-832', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Łukasz Szarpak', 'role': 'CONTACT', 'email': 'lukasz.szarpak@gmail.com', 'phone': '500186225'}], 'facility': 'Łukasz Szarpak', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Lukasz Szarpak, PhD', 'role': 'CONTACT', 'email': 'lukasz.szarpak@gmail.com', 'phone': '500186225'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Łukasz Szarpak', 'investigatorFullName': 'Łukasz Szarpak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}