Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-08 @ 1:51 PM
Study NCT ID:
NCT03242733
Status:
UNKNOWN
Last Update Posted:
2018-04-24
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound assessment of the presence of gastric contents.', 'timeFrame': 'Before the induction of anesthesia (Baseline)', 'description': 'The presence of of gastric contents is assessed by using ultrasonography; yes/no'}], 'secondaryOutcomes': [{'measure': 'Ultrasound assessment of the component of residual gastric contents', 'timeFrame': 'Before the induction of anesthesia (Baseline)', 'description': 'The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastroparesis'], 'conditions': ['Hip Fractures']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.', 'detailedDescription': 'In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.\n\nIn the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Who has hip fracture and agrees with the purpose of the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who has hip fracture and agrees with the purpose of the study\n\nExclusion Criteria:\n\n* gastrointestinal pathology\n* history of any type of gastrectomy\n* gastrointestinal anomaly'}, 'identificationModule': {'nctId': 'NCT03242733', 'briefTitle': 'Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip', 'orgStudyIdInfo': {'id': '20170804/10/2017/8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hip fracture patients', 'description': 'Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled.', 'interventionNames': ['Other: Ultrasound assessment of gastric contents']}], 'interventions': [{'name': 'Ultrasound assessment of gastric contents', 'type': 'OTHER', 'description': 'Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.', 'armGroupLabels': ['Hip fracture patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Young Hwang, M.D.', 'role': 'CONTACT', 'email': 'mistyblue15@naver.com', 'phone': '+82-2-870-2518'}], 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin-Young Hwang, MD, phD', 'role': 'CONTACT', 'email': 'mistyblue15@naver.com', 'phone': '82-10-9553-0916'}], 'overallOfficials': [{'name': 'Jin-Young Hwang, MD,phD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Boramae Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}