Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT05907460
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of sustained return of spontaneous circulation (ROSC)', 'timeFrame': '20 minutes after ROSC', 'description': "successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes"}], 'secondaryOutcomes': [{'measure': 'Rate of any return of spontaneous circulation', 'timeFrame': '1 minutes after ROSC', 'description': "successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR)"}, {'measure': 'Rate of survival to ICU admission', 'timeFrame': '48 hours after ROSC', 'description': "Successful restoration and stabilization of a patient's heartbeat and circulation, enabling safe transfer to the ICU."}, {'measure': 'Rate of survival to discharge', 'timeFrame': '6 months after ROSC', 'description': "successful restoration and maintenance of a patient's heartbeat and blood circulation and able to complete treatment course till discharge"}, {'measure': 'Rate of discharge with favorable neurological outcomes', 'timeFrame': '6 months after ROSC', 'description': "using cerebral performance category score to measure neurologic outcomes of the patient at the time while patient's discharge. CPC1 and 2 are consider as favorable neurological outcomes, CPC3 and 4 are consider as unfavorable neurological outcomes"}, {'measure': 'end-tidal carbon dioxide (EtCO2)', 'timeFrame': 'During resuscitation', 'description': 'measuring end-tidal carbon dioxide during resuscitation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Out-Of-Hospital Cardiac Arrest', 'Chest compression site', 'transesophageal echocardiography', 'end-tidal CO2'], 'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': "The purpose of this single center, randomized clinical control trial is to determine that changing chest compression site during cardiopulmonary resuscitation according to the examination of the TEE could increase the level of end-tidal CO2, which represents the quality of cardiopulmonary resuscitation, or not in adult patients with non-traumatic out-of-hospital cardiac arrest while comparing to those who don't receive examination of transesophageal echocardiography during cardiopulmonary resuscitation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 20 years-old\n2. Out-of-hospital cardiac arrest\n3. Non-trauma\n\nExclusion Criteria:\n\n1. Obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc.\n2. Family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation.\n3. Patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc.\n4. Received Extracorporeal CPR.\n5. Achieving sustained ROSC before ED arrival'}, 'identificationModule': {'nctId': 'NCT05907460', 'acronym': 'EXECT_CPR', 'briefTitle': 'EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': '109070-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Perform standard advanced life support. No examination of transesophageal echocardiography during cardiopulmonary resuscitation.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Perform examination of transesophageal echocardiography during cardiopulmonary resuscitation and adjust the chest compression site to avoid left ventricular outflow tract according to the result of transesophageal echocardiography', 'interventionNames': ['Device: transesophageal echocardiography examination during cardiopulmonary resuscitation']}], 'interventions': [{'name': 'transesophageal echocardiography examination during cardiopulmonary resuscitation', 'type': 'DEVICE', 'description': 'Perform transesophageal echocardiography in patients with out-of-hospital cardiac arrest during cardiopulmonary resuscitation and adjust the chest compression site to compress the left ventricle and avoid left ventricular outflow tract.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Banqiao District', 'state': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'overallOfficials': [{'name': 'Jun-Tang Sun, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Attending physician of emergency medicine department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}