Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 12:13 PM
Study NCT ID:
NCT05435157
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual gastric volume', 'timeFrame': 'Preoperative', 'description': 'Residual gastric volume measured by ultrasounds'}], 'secondaryOutcomes': [{'measure': 'Antral cross-sectional area', 'timeFrame': 'Preoperative', 'description': 'Antral cross-sectional area measured by ultrasounds'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Gastric ultrasound', 'Full stomach', 'Surgery'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '39116006', 'type': 'BACKGROUND', 'citation': 'Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery', 'detailedDescription': 'The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fasted diabetic and non-diabetic patients scheduled for surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI\\<40 kg.m-2;\n* Age over 18 years;\n* American Society of Anesthesiologists' physical status status I-III\n* who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Recent upper gastrointestinal bleed (\\< 1 month)\n* Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)\n* Previous surgical procedures on the esophagus, stomach, or upper abdomen\n* Gastroesophageal reflux disease\n* Previous use of prokinetics or high doses of opiates."}, 'identificationModule': {'nctId': 'NCT05435157', 'briefTitle': 'Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León'}, 'officialTitle': 'Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.', 'orgStudyIdInfo': {'id': 'PI 2022 02 934'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic patients', 'description': 'Diabetic patients undergoing scheduled surgery'}, {'label': 'Non-diabetic patients', 'description': 'Non-diabetic patients undergoing sheduled surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'facility': 'IBSAL', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'José A. Sastre, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology Service. Salamanca University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Alfonso Sastre', 'investigatorAffiliation': 'Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León'}}}}