Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 12:04 AM
Study NCT ID:
NCT00951704
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2009-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2009-07-31', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in hemodynamics, Change in cerebral saturation, Change in quality of CPR', 'timeFrame': 'During resuscitation'}], 'primaryOutcomes': [{'measure': 'The success rate of current guidelines (depth and frequency of chest compression, epidemiology)', 'timeFrame': 'During the resuscitation'}, {'measure': 'Quality of life after CA', 'timeFrame': '6 months', 'description': 'Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt'}], 'secondaryOutcomes': [{'measure': 'Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2', 'timeFrame': 'During the resuscitation'}, {'measure': 'survival of cardiac arrest', 'timeFrame': 'hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CPR', 'Tissue Perfusion', 'invasive arterial pressure', 'exhaled carbon dioxide', 'Quality of life', 'Quality of chest compressions', 'Epidemiology of sudden cardiac arrest(OHCA)'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '29845604', 'type': 'DERIVED', 'citation': 'Kangasniemi H, Setala P, Huhtala H, Kamarainen A, Virkkunen I, Jamsen E, Yli-Hankala A, Hoppu S. Out-of-hospital cardiac arrests in nursing homes and primary care facilities in Pirkanmaa, Finland. Acta Anaesthesiol Scand. 2018 Oct;62(9):1297-1303. doi: 10.1111/aas.13152. Epub 2018 May 29.'}, {'pmid': '29797706', 'type': 'DERIVED', 'citation': 'Setala P, Hellevuo H, Huhtala H, Kamarainen A, Tirkkonen J, Hoppu S. Risk factors for cardiopulmonary resuscitation-related injuries sustained during out-of-hospital cardiac arrests. Acta Anaesthesiol Scand. 2018 Oct;62(9):1290-1296. doi: 10.1111/aas.13155. Epub 2018 May 24.'}, {'pmid': '29769232', 'type': 'DERIVED', 'citation': 'Setala PA, Virkkunen IT, Kamarainen AJ, Huhtala HSA, Virta JS, Yli-Hankala AM, Hoppu SE. End-tidal carbon dioxide output in manual cardiopulmonary resuscitation versus active compression-decompression device during prehospital quality controlled resuscitation: a case series study. Emerg Med J. 2018 Jul;35(7):428-432. doi: 10.1136/emermed-2017-207103. Epub 2018 May 16.'}, {'pmid': '26310837', 'type': 'DERIVED', 'citation': 'Sainio M, Hoppu S, Huhtala H, Eilevstjonn J, Olkkola KT, Tenhunen J. Simultaneous beat-to-beat assessment of arterial blood pressure and quality of cardiopulmonary resuscitation in out-of-hospital and in-hospital settings. Resuscitation. 2015 Nov;96:163-9. doi: 10.1016/j.resuscitation.2015.08.004. Epub 2015 Aug 24.'}, {'pmid': '23819769', 'type': 'DERIVED', 'citation': 'Sainio M, Sutton RM, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT, Nadkarni VM, Hoppu S. Association of arterial blood pressure and CPR quality in a child using three different compression techniques, a case report. Scand J Trauma Resusc Emerg Med. 2013 Jul 2;21:51. doi: 10.1186/1757-7241-21-51.'}, {'pmid': '23816325', 'type': 'DERIVED', 'citation': 'Sainio M, Kamarainen A, Huhtala H, Aaltonen P, Tenhunen J, Olkkola KT, Hoppu S. Real-time audiovisual feedback system in a physician-staffed helicopter emergency medical service in Finland: the quality results and barriers to implementation. Scand J Trauma Resusc Emerg Med. 2013 Jul 1;21:50. doi: 10.1186/1757-7241-21-50.'}, {'pmid': '21764499', 'type': 'DERIVED', 'citation': 'Hoppu S, Sainio M, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT. Blood pressure during resuscitation in man--the effect of pause during rhythm analysis revisited. Resuscitation. 2011 Nov;82(11):1460-3. doi: 10.1016/j.resuscitation.2011.06.005. Epub 2011 Jun 17.'}]}, 'descriptionModule': {'briefSummary': "The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and also the associations between depth and frequency of chest compressions and invasive arterial pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions 1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals and 2) in-hospital by hospital resuscitation team members. In addition, the investigators will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2 and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR device. The results will give the investigators important insights into the haemodynamics of CPR which may guide future strategies for the management of cardiac arrest. The research group is also interested in CPR related injuries and mattress effect. Quality of life after CA is evaluated among survivals and the cause of death among non-survivors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population \\>18 years of age with cardiac arrest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac arrest\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* \\< 18 years of age'}, 'identificationModule': {'nctId': 'NCT00951704', 'briefTitle': 'Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Evaluating the Quality of Prehospital and In-hospital Cardio-pulmonary Resuscitation - Comparing the Compressions to Concurrent Vital Signs (Invasive Blood Pressure, Cerebral Oxygen Saturation, EtCO2) and Iatrogenic Injuries Associated to Chest Compressions.', 'orgStudyIdInfo': {'id': 'R08116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac arrest'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Department of Anesthesiology and Intensive Care, Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Jyrki Tenhunen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Critical Care Medicine Research Group'}, {'name': 'Sanna Hoppu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Marko Sainio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Klaus Olkkola, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology and Intensive Care, Helsinki University Hospital'}, {'name': 'Heidi Hellevuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Piritta Setälä, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Ilkka Virkkunen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Heidi Kangasniemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Joonas Tamminen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}