Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 4:44 AM
Study NCT ID:
NCT06038734
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retained gastric contents', 'timeFrame': 'At time of pre-operative assessment', 'description': 'Presence of retained gastric contents, either liquid or solid'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1 agonists', 'retained gastric contents', 'glucagon-like peptide receptor-1 agonists', 'perioperative'], 'conditions': ['Delayed Gastric Emptying', 'Gastroparesis']}, 'descriptionModule': {'briefSummary': 'Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include non-critically ill adults 18 years and older undergoing various elective surgical procedures at the University of North Carolina Medical Center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GLP-1 agonist use within previous 30 days\n* Appropriately fasted per standard guidelines\n\nExclusion Criteria:\n\n* History of gastric surgery / gastric volume reduction\n* Critical illness\n* Inability to provide informed consent\n* \\<18 years of age'}, 'identificationModule': {'nctId': 'NCT06038734', 'briefTitle': 'Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.', 'orgStudyIdInfo': {'id': '23-0578'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GLP-1 agonists', 'description': 'Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are using GLP-1 agonist medications.', 'interventionNames': ['Diagnostic Test: gastric ultrasound']}, {'label': 'Control', 'description': 'Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are not using GLP-1 agonist medications.', 'interventionNames': ['Diagnostic Test: gastric ultrasound']}], 'interventions': [{'name': 'gastric ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Utilize POC gastric ultrasound to identify the presence of retained gastric contents.', 'armGroupLabels': ['Control', 'GLP-1 agonists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Medical Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Lindsey Gouker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 9 and continuing for 36 months following publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}