Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03438305
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of residual gastric volume in longstanding diabetic patients', 'timeFrame': 'intra-operative', 'description': 'To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients'}], 'secondaryOutcomes': [{'measure': 'correlation between preoperative gastric US findings and fasting hours in both groups', 'timeFrame': 'intraoperative', 'description': 'To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '30609007', 'type': 'DERIVED', 'citation': 'Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume \\>1.5 ml/kg) during the preoperative period in longstanding diabetic patients.\n\nStudy population :\n\n* -Longstanding diabetic patients (group D)\n* -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.\n\nSuction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.\n\nSecond set of analysis will be finding correlation between US findings and suction volume in two groups.\n\nOutcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.\n\nSample Size ; was calculated as 48 patients (24) in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages from 40 to 60 years old.\n* American Society of Anesthiologist (ASA) II.\n* Diabetic patients with longstanding duration(more than 6 years).\n\nExclusion Criteria:\n\n* Age \\<40,\\>60 years .\n* Pregnant female\n* Obese patients (BMI ≤40)\n* Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.\n* Diabetic patients less than 6 years.'}, 'identificationModule': {'nctId': 'NCT03438305', 'briefTitle': 'Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).', 'orgStudyIdInfo': {'id': 'N-74-2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group D', 'interventionNames': ['Other: sonar assessment of gastric volume in Diabetic patients']}, {'label': 'Group N', 'interventionNames': ['Other: sonar assessment of gastric volume in Non Diabetic patients']}], 'interventions': [{'name': 'sonar assessment of gastric volume in Diabetic patients', 'type': 'OTHER', 'description': 'assessment of gastric volume in Diabetic Patients', 'armGroupLabels': ['Group D']}, {'name': 'sonar assessment of gastric volume in Non Diabetic patients', 'type': 'OTHER', 'description': 'assessment of gastric volume in Non- Diabetic Patients', 'armGroupLabels': ['Group N']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthiology', 'investigatorFullName': 'Sherin Refaat', 'investigatorAffiliation': 'Cairo University'}}}}