Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2026-01-10 @ 4:04 AM
Study NCT ID:
NCT02588495
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2015-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004435', 'term': 'Eating'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound\'s sensitivity to identify a "full stomach"', 'timeFrame': '5 minutes', 'description': 'Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids'}], 'secondaryOutcomes': [{'measure': 'Ultrasound\'s accuracy in detecting a "full stomach"', 'timeFrame': '5 minutes', 'description': "Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion"}, {'measure': 'Inter/Intra-rater reliability of observer in detecting a "full stomach"', 'timeFrame': '5 minutes', 'description': 'Determining the reliability of observers in being able to similarly detect a full stomach'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Gastric area', 'Accuracy', 'Aspirate'], 'conditions': ['Aspiration']}, 'referencesModule': {'references': [{'pmid': '29624530', 'type': 'DERIVED', 'citation': 'Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.'}]}, 'descriptionModule': {'briefSummary': "During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. 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\nThe purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged 18 to 85 years\n* Male or female\n* American Society of Anesthesia physical status classification I and II\n* Height greater than 145 cm\n* Ability to understand the study protocol and provide informed consent\n\nExclusion Criteria:\n\n* Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)\n* History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)'}, 'identificationModule': {'nctId': 'NCT02588495', 'briefTitle': 'Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework', 'orgStudyIdInfo': {'id': '14-7883-BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Fasting', 'description': 'Participant will remain fasted following initial gastric ultrasound'}, {'type': 'EXPERIMENTAL', 'label': 'Food intake', 'description': 'Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound', 'interventionNames': ['Other: Food intake']}], 'interventions': [{'name': 'Food intake', 'type': 'OTHER', 'description': 'Either drinking a cup of clear liquid, or having a cup of coffee and a muffin', 'armGroupLabels': ['Food intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Anahi Perlas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff Anesthesiologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}