Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-04 @ 10:46 AM
Study NCT ID:
NCT02888951
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of Gastric Contents', 'timeFrame': 'Less than two hour prior to surgery', 'description': 'A "full stomach" is defined as one containing a) solid or thick fluid content or b) \\> 1.5 mL/kg of clear fluid.\n\nThere are 4 categories regarding gastric contents:\n\n1. Empty Stomach\n2. Grade 1 Clear Fluid (fluid only observed in supine or right lateral decubitus position)\n3. Grade 2 Clear Fluid (fluid only observed in both supine and right lateral decubitus position)\n4. Solid'}], 'secondaryOutcomes': [{'measure': 'Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients', 'timeFrame': 'Less than two hour prior to surgery', 'description': 'Characterize the distribution of baseline gastric volume in fasted diabetic and non-diabetic patients'}, {'measure': 'Define the upper limit of normal fasting gastric volume defined as the 95th percentile', 'timeFrame': 'Less than two hour prior to surgery', 'description': 'Define the upper limit of normal fasting gastric volume defined as the 95th percentile'}, {'measure': 'Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients', 'timeFrame': 'Less than two hour prior to surgery', 'description': 'To study the association between type of diabetes mellitus (I or II), duration and degree of glycemic control with baseline gastric fluid volume'}, {'measure': 'Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.', 'timeFrame': 'Less than two hour prior to surgery', 'description': 'To study the relationship between gastric volume in diabetic patients in relation with which medication and/or treatment they use to manage their diabetes. Examples of medication or treatment include; pharmaceutical hypoglycemics, insulin, or diet controlled.'}, {'measure': 'Episodes of intra-operative regurgitation, vomiting or aspiration', 'timeFrame': 'Intraoperative', 'description': 'Episodes of intra-operative regurgitation, vomiting or aspiration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Diabetes Mellitus', 'Gastric Ultrasound', 'Preoperative fasting', 'Empty Stomach', 'Gastric Diabetes'], 'conditions': ['Diabetes', 'Diabetes Mellitus', 'Diabetes Mellitus Type 1', 'Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.', 'detailedDescription': "Any surgical procedure carries an inherent risk of pulmonary aspiration. Food or liquid from the stomach might be forced back up the throat from where it could enter the lungs (aspiration) resulting in serious complications prolonging the hospital stay or in extreme circumstances death.\n\nThe risk of this is slightly higher in diabetics when compared to non-diabetics as the emptying of contents from the stomach is slightly delayed. This is why people going for surgery are asked not to eat for a specific time before their surgery. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.\n\nThis study aims to evaluate the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. The investigators also aim to find an association between the type and duration of diabetes mellitus with residual gastric volume. Episodes of intra-operative regurgitation, vomiting or aspiration will also be documented."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be patients whom are scheduled to undergo elective surgical procedures requiring preoperative fasting period of at least 8 hours. 240 patients will be recruited in total. One cohort consisting 120 patients will be diabetic (type 1 or 2). The other cohort consisting of 120 patients will be non-diabetic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective surgery aged 18 to 85 years\n* American Society of Anesthesia physical status classification I to III\n* Body mass index \\< 40 kg/ cm2.\n\nExclusion Criteria:\n\n* Pregnancy (currently or within the past 3 months)\n* Previous surgery of the upper gastrointestinal tract\n* Achalasia'}, 'identificationModule': {'nctId': 'NCT02888951', 'briefTitle': 'Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study', 'orgStudyIdInfo': {'id': '15-8808-AE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic Group', 'description': 'A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.'}, {'label': 'Non-Diabetic Group', 'description': 'A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anahi Perlas, MD', 'role': 'CONTACT', 'email': 'anahi.perlas@uhn.ca', 'phone': '(416) 603-5800', 'phoneExt': '5118'}, {'name': 'Didem Bozak', 'role': 'CONTACT', 'email': 'didem.bozak@uhnresearch.ca', 'phone': '(416) 603-5800', 'phoneExt': '2016'}, {'name': 'Anahi Perlas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vincent Chan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Anahi Perlas, MD', 'role': 'CONTACT', 'email': 'anahi.perlas@uhn.ca', 'phone': '(416) 603-5800', 'phoneExt': '5118'}, {'name': 'Didem Bozak', 'role': 'CONTACT', 'email': 'didem.bozak@uhnresearch.ca', 'phone': '(416) 603-5800', 'phoneExt': '2016'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is undecided at this time whether data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}