Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 10:45 AM
Study NCT ID:
NCT04451733
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ETI Performance on CPR Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good Neurologic outcome', 'timeFrame': '1 year', 'description': 'survival with good neurologic status (CPC 1-2) after suffering cardiac arrest'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intubation', 'Cardiopulmonary Arrest'], 'conditions': ['Cardiopulmonary Arrest']}, 'referencesModule': {'references': [{'pmid': '32534981', 'type': 'BACKGROUND', 'citation': 'Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.'}, {'pmid': '31722552', 'type': 'BACKGROUND', 'citation': 'Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.'}, {'pmid': '30111343', 'type': 'BACKGROUND', 'citation': 'Newell C, Grier S, Soar J. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation. Crit Care. 2018 Aug 15;22(1):190. doi: 10.1186/s13054-018-2121-y.'}, {'pmid': '26472995', 'type': 'BACKGROUND', 'citation': "Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients.', 'detailedDescription': 'ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known detailed data of explaining this issues.\n\nThis study tried to evaluate effect of factors of ETI including numbers of trial, time for ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients in an urban emergency department at a tertiary hospital in Seoul, Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who suffered sudden cardiac arrest and intubated during CPR\n\nExclusion Criteria:\n\n* case of requesting the do-not-atempt resuscitation\n* patients who were diagnosed as adavanced cancer\n* cardiac arrest by multiple trauma'}, 'identificationModule': {'nctId': 'NCT04451733', 'briefTitle': 'Effect of ETI Performance on CPR Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Effect of Endotracheal Intubation Performance on the Outcomes in out-of Hospital Cardiac Arrest Patients', 'orgStudyIdInfo': {'id': 'INTU_CPRoutcome'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endotracheal intubation', 'type': 'PROCEDURE', 'description': 'Perform the endotracheal intubation during CPR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Emergency Medicine, Konkuk University Medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang O Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sang O, Park', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}