Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT00641069
Status:
COMPLETED
Last Update Posted:
2009-07-15
First Post:
2008-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Chest Compression in Cardiac Arrest
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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-14', 'studyFirstSubmitDate': '2008-03-18', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient', 'timeFrame': 'Instantaneously'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient', 'timeFrame': 'Instantaneously'}, {'measure': 'Mean blood pressures produced by manual and then by automated chest compressions will be recorded for each patient', 'timeFrame': 'Instantaneously'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac arrest', 'Cardiopulmonary resuscitation'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.', 'detailedDescription': 'The protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (AutoPulse™ 100, Zoll®) with those of manual cardiopulmonary resuscitation in refractory out-of-hospital cardiac arrest. Each patient will receive first manual compressions and then automated resuscitation.\n\nPatients presenting with cardiac arrest are treated following standard advanced life support guidelines. They are intubated and ventilated, received epinephrine and defibrillation if appropriate. Manuel chest compressions are continued. An arterial catheter is placed to monitor hemodynamics continuously as we usually do in this case. Patients are included at this stage. Three blood pressure values (every 1 minutes) are recorded. Then, the automated band device is started up without any pause, following our procedure for refractory cardiac arrest. Three blood pressure values are recorded again, during automated cardiopulmonary resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged \\> 18 with out-of-hospital cardiac arrest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Refractory cardiac arrest\n\nExclusion Criteria:\n\n* Defective invasive arterial blood pressure monitoring'}, 'identificationModule': {'nctId': 'NCT00641069', 'briefTitle': 'Automated Chest Compression in Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Beaujon Hospital'}, 'officialTitle': 'Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation', 'orgStudyIdInfo': {'id': 'BAND V6'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Automated load-distributing band device', 'type': 'DEVICE', 'otherNames': ['AutoPulse™ 100, Zoll®'], 'description': 'Blood pressure recording before and after starting up the automated band device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}], 'overallOfficials': [{'name': 'Francois-Xavier Duchateau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital'}, {'name': 'Jean Mantz, MDPhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaujon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'François-Xavier Duchateau, MD', 'oldOrganization': 'Departement of Anesthesiology, Intensive Care and EMS, Beaujon Hospital'}}}}