Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT03184532
Status:
UNKNOWN
Last Update Posted:
2017-06-12
First Post:
2017-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gastric volume', 'timeFrame': 'bedside test 5 minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluation of ASA Fasting Recommendations in Diabetic Patients']}, 'descriptionModule': {'briefSummary': 'To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective orthopedic procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective orthopedic procedures.\n\nExclusion Criteria:\n\n* Patients with BMI \\> 35 kg.m-2, age \\<18y, ASA physical state \\>II, fasting more than 6hs, or with gastric diseases will be excluded'}, 'identificationModule': {'nctId': 'NCT03184532', 'acronym': 'gastric US', 'briefTitle': 'Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Healthpoint Hospital'}, 'officialTitle': 'Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients', 'orgStudyIdInfo': {'id': 'rec003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'D', 'description': 'diabetic patients', 'interventionNames': ['Diagnostic Test: ultrasound']}, {'label': 'ND', 'description': 'non-diabetic patients', 'interventionNames': ['Diagnostic Test: ultrasound']}], 'interventions': [{'name': 'ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound examination of pyloric antrum', 'armGroupLabels': ['D', 'ND']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Sayed Elahl, MD', 'role': 'CONTACT', 'email': 'm.elahl@healthpoint.ae', 'phone': '00971501257051'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesia consultant', 'investigatorFullName': 'Mohamed Ibrahim Elahl', 'investigatorAffiliation': 'Healthpoint Hospital'}}}}