Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02391857
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean compression depth of Chest compression', 'timeFrame': 'Within 10-20 min of CPR'}, {'measure': 'Mean compression rate of Chest compression', 'timeFrame': 'Within 10-20 min of CPR'}, {'measure': 'proportions of corrected release of Chest compression', 'timeFrame': 'Within 10-20 min of CPR'}], 'primaryOutcomes': [{'measure': 'Evidence of improvement of circulatuion during CPR by evalution of increased end tidal CO2 (ETCO2) durig CPR', 'timeFrame': 'Within 10-20 min of CPR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiopulmonary resuscitation', 'Gastric emptying'], 'conditions': ['Out-of-Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '9863573', 'type': 'BACKGROUND', 'citation': 'Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8. doi: 10.1016/s0300-9572(98)00095-1.'}, {'pmid': '16192785', 'type': 'BACKGROUND', 'citation': 'Gabrielli A, Wenzel V, Layon AJ, von Goedecke A, Verne NG, Idris AH. Lower esophageal sphincter pressure measurement during cardiac arrest in humans: potential implications for ventilation of the unprotected airway. Anesthesiology. 2005 Oct;103(4):897-9. doi: 10.1097/00000542-200510000-00031. No abstract available.'}, {'pmid': '20956221', 'type': 'BACKGROUND', 'citation': 'Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939.'}, {'pmid': '9468177', 'type': 'BACKGROUND', 'citation': 'Wenzel V, Idris AH, Banner MJ, Kubilis PS, Williams JL Jr. Influence of tidal volume on the distribution of gas between the lungs and stomach in the nonintubated patient receiving positive-pressure ventilation. Crit Care Med. 1998 Feb;26(2):364-8. doi: 10.1097/00003246-199802000-00042.'}, {'pmid': '15531063', 'type': 'BACKGROUND', 'citation': 'von Goedecke A, Wagner-Berger HG, Stadlbauer KH, Krismer AC, Jakubaszko J, Bratschke C, Wenzel V, Keller C. Effects of decreasing peak flow rate on stomach inflation during bag-valve-mask ventilation. Resuscitation. 2004 Nov;63(2):131-6. doi: 10.1016/j.resuscitation.2004.04.012.'}, {'pmid': '15066941', 'type': 'BACKGROUND', 'citation': 'Aufderheide TP, Sigurdsson G, Pirrallo RG, Yannopoulos D, McKnite S, von Briesen C, Sparks CW, Conrad CJ, Provo TA, Lurie KG. Hyperventilation-induced hypotension during cardiopulmonary resuscitation. Circulation. 2004 Apr 27;109(16):1960-5. doi: 10.1161/01.CIR.0000126594.79136.61. Epub 2004 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to identify the effect of early gastric decompression on the improvement of circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting of emergency department.', 'detailedDescription': 'Subjects and setting : adult sudden cardiac arrest patients in out of hospital, and transported to emergency department for advanced resuscitation treatment Interventions: first step, establish the advanced airway, after then insertion the naso (or oro)-gastric tube during CPR Data collection: live observation and review the automatically recoding data Missing or failed data should be collected and descriped Study period and sample size: numbers of participants necessary to identify the effect of interventions; 12 months or lesser were anticipated Analysis: All collected data can be analysed by Statistical programs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out of cardiac arrest patients who was transported to the emergency department for advanced resuscitation care\n\nExclusion Criteria:\n\n* Do not attempted\n* Inevitable death cofirmed at Emergency department\n* Early recovery of spontaneous circulation before the intervention or sufficient collections of outcome data\n* data loss\n* others'}, 'identificationModule': {'nctId': 'NCT02391857', 'acronym': 'EGD_ACLS', 'briefTitle': 'Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'The Clinical Study for the Identifying the Effect of Early Gastric Decompression on Improvement of Circulation During Advanced Cardiopulmonary Resuscitation', 'orgStudyIdInfo': {'id': 'EGD2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGDgroup', 'description': 'Intervention (gastric decompression by naso(oro)-gastric tube insertion) was performed', 'interventionNames': ['Procedure: Gastric decompression']}], 'interventions': [{'name': 'Gastric decompression', 'type': 'PROCEDURE', 'description': 'Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR', 'armGroupLabels': ['EGDgroup']}]}, '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', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Emergency Medicine, School of medicine, Konkuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sang O, Park', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}