Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 6:47 PM
Study NCT ID:
NCT05609357
Status:
UNKNOWN
Last Update Posted:
2023-08-09
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and portion of participants with serious or non-serious adverse event', 'timeFrame': 'Up to 1 day', 'description': 'e.g. event of fall, failure of intubation'}], 'secondaryOutcomes': [{'measure': 'Number and portion of participants with repeated CPR', 'timeFrame': 'up to 1 day'}, {'measure': 'Number and portion of participants with survival to emergency department discharge', 'timeFrame': 'up to 1 day'}, {'measure': 'Number and portion of participants with sustained return of spontaneous circulation', 'timeFrame': 'Up to 1 day', 'description': 'sustained ROSC ≥ 20 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac arrest', 'Head-up Cardiopulmonary Resuscitation'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Head up CPR with impedance threshold device(ITD) and active compression-decompression (ACD) has been proved to improve both cerebral and coronary perfusion pressure during resuscitation in animal models. Increased rates of Spontaneous Circulation (ROSC) were also observed in cardiac arrest patients.\n\nThe goal of this clinical trial is to learn about the feasibility and safety of Head-up Cardiopulmonary Resuscitation in patients with non-traumatic cardiac arrest. Participants will be received head-up CPR during resuscitation. The main question it aims to answer is if there is any adverse or unfavorable event during resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-traumatic cardiac arrest\n* Age ≥ 20\n\nExclusion Criteria:\n\n* Trauma\n* Age \\< 20\n* Pregnancy\n* Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition)\n* Disorder of cervical spine'}, 'identificationModule': {'nctId': 'NCT05609357', 'briefTitle': 'The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research', 'orgStudyIdInfo': {'id': '202204040DIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Head-up Cardiopulmonary Resuscitation', 'interventionNames': ['Device: Head-up Cardiopulmonary Resuscitation']}], 'interventions': [{'name': 'Head-up Cardiopulmonary Resuscitation', 'type': 'DEVICE', 'description': "Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation", 'armGroupLabels': ['Head-up Cardiopulmonary Resuscitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Hsien Lin', 'role': 'CONTACT', 'email': '47ienn@gmail.com'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chih-Hsien Lin', 'role': 'CONTACT', 'email': '47ienn@gmail.com', 'phone': '+886972653698'}, {'name': 'Wei-Ting Chen', 'role': 'CONTACT', 'email': 'biochip52@hotmail.com', 'phone': '+88623123456#26283'}], 'overallOfficials': [{'name': 'Wei-Ting Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Chien-Hua Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Min-Shan Tsai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Chih-Hsien Lin', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}