Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT06210867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Associated With Occluding the Upper Esophagus by Paratracheal Force
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of esophageal occlusion rate', 'timeFrame': '10 sec', 'description': 'Esophageal occlusion is defined as passing an esophageal stethoscope'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '8424572', 'type': 'BACKGROUND', 'citation': 'Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.'}, {'pmid': '17122571', 'type': 'BACKGROUND', 'citation': 'Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.'}, {'pmid': '19304443', 'type': 'BACKGROUND', 'citation': 'Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.'}, {'pmid': '28203725', 'type': 'BACKGROUND', 'citation': 'Van de Putte P, Vernieuwe L, Jerjir A, Verschueren L, Tacken M, Perlas A. When fasted is not empty: a retrospective cohort study of gastric content in fasted surgical patientsdagger. Br J Anaesth. 2017 Mar 1;118(3):363-371. doi: 10.1093/bja/aew435.'}, {'pmid': '30288741', 'type': 'BACKGROUND', 'citation': 'Gautier N, Danklou J, Brichant JF, Lopez AM, Vandepitte C, Kuroda MM, Hadzic A, Gautier PE. The effect of force applied to the left paratracheal oesophagus on air entry into the gastric antrum during positive-pressure ventilation using a facemask. Anaesthesia. 2019 Jan;74(1):22-28. doi: 10.1111/anae.14442. Epub 2018 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure.', 'detailedDescription': 'Measure the sternomental distance, thyromental distance, neck length, neck circumference, Mallampati score, BMI, Neck motion, inter-incisor gap, thyrosternal distance. And analysis these factors are associated with upper esophageal occlusion or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients were scheduled for general anesthesia without a risk of difficult intubation or a history of head and neck surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 19 years old\n* schedule for general anesthesia\n\nExclusion Criteria:\n\n* Limited neck extension\n* Abnormality or anomaly, history of surgery in the neck, esophagus, face, upper airway part.\n* Who has weak teeth\n* Who has pulmonary aspiration risk'}, 'identificationModule': {'nctId': 'NCT06210867', 'briefTitle': 'Factors Associated With Occluding the Upper Esophagus by Paratracheal Force', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Factors Associated With Occluding the Upper Esophagus by Paratracheal Force', 'orgStudyIdInfo': {'id': '10-2022-111'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Young Hwang, MD,PhD', 'role': 'CONTACT', 'email': 'mistyblue15@naver.com', 'phone': '82-2-870-2851'}], 'facility': 'Jin-Young Hwang', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin-Young Hwang, MD,PhD', 'role': 'CONTACT', 'email': 'mistyblue15@naver.com', 'phone': '82-2-870-2851'}], 'overallOfficials': [{'name': 'Jin-Young Hwang, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}