Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-29 @ 4:52 PM
Study NCT ID:
NCT06600035
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Ultrasound in Elective Surgical Diabetic Patients
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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antral cross-sectional area (CSA)', 'timeFrame': 'Just before surgery', 'description': 'Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:\n\nCSA = (AP × CC × π)/4'}], 'secondaryOutcomes': [{'measure': 'Gastric volume', 'timeFrame': 'Just before surgery', 'description': 'The gastric volume will be calculated using the previously validated formula:\n\nGVe (gastric volume in ml) = 27.0 + \\[14.6 × right - lateral CSA (cm2)\\] - (1.28 × age)'}, {'measure': 'Gastric volume/weight', 'timeFrame': 'Just before surgery', 'description': 'Gastric volume/weight will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Ultrasound', 'Elective Surgery', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.', 'detailedDescription': "Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between \\<0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.\n\nConsequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.\n\nUltrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.\n\nAs a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This case-control study will be carried out on 130 cases, aged ≥ 18 years, undergoing elective surgery at Tanta University Hospitals after approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Both sexes.\n* Undergoing elective surgery.\n\nExclusion Criteria:\n\n* American Society of Anesthesiology (ASA) physical status \\>III.\n* Body mass index (BMI) outside the range of 18.5-40 Kg/m2.\n* History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.\n* Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).\n* Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).\n* Hypothyroidism.\n* Current smoking history.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06600035', 'briefTitle': 'Gastric Ultrasound in Elective Surgical Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Gastric Ultrasound in Elective Surgical Diabetic Patients', 'orgStudyIdInfo': {'id': '36264PR801/8/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I - Diabetic', 'description': 'Diabetic patients', 'interventionNames': ['Device: Gastric ultrasound']}, {'label': 'Group II - Non-diabetic', 'description': 'Non-diabetic patients', 'interventionNames': ['Device: Gastric ultrasound']}], 'interventions': [{'name': 'Gastric ultrasound', 'type': 'DEVICE', 'description': 'A curved array, low-frequency (2-5 MHz) transducer providing a scan depth up to 30 cm will be used. Patients will be scanned in the supine position followed by right lateral decubitus (RLD) position. The sonographic appearance of the gastric antrum will be classified as Grade 0,1 or 2, signifying empty antrum, fluid detected in RLD position only and antral fluid in both supine and RLD positions, respectively, based on the appearance in both the positions. Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:CSA = (AP × CC × π)/4', 'armGroupLabels': ['Group I - Diabetic', 'Group II - Non-diabetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed S Elsharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}, {'name': 'Mohammad H Alqassas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed E Abo ElKheir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohammed S ElSharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}