Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT04760106
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Learning Curves of Gastric Ultrasound for Novel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2021-02-07', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of qualitative ultrasound assessment of gastric content in novel gastric sonographers', 'timeFrame': '3 months', 'description': 'Number of volunteers which novel gastric sonographers are correct to identify whether is empty, fluid or solid (percentage)'}], 'secondaryOutcomes': [{'measure': 'An interrater reliability of the quantitative ultrasound assessment of the gastric volume', 'timeFrame': '3 months', 'description': 'Using the result of cross sectional area from both novel gastric sonographers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric ultrasound', 'Learning curve', 'Accuracy', 'Reliability', 'Novel in gastric ultrasound'], 'conditions': ['Gastric Ultrasound', 'Learning Curve', 'Novel in Gastric Ultrasound']}, 'referencesModule': {'references': [{'pmid': '34979932', 'type': 'DERIVED', 'citation': 'Tankul R, Halilamien P, Tangwiwat S, Dejarkom S, Pangthipampai P. Qualitative and quantitative gastric ultrasound assessment in highly skilled regional anesthesiologists. BMC Anesthesiol. 2022 Jan 3;22(1):5. doi: 10.1186/s12871-021-01550-z.'}]}, 'descriptionModule': {'briefSummary': 'Various studies have shown that gastric sonography can reliably provide information on both qualitative (nature of content) and quantitative (volume) aspects of gastric content. A recent study has suggested that a minimum of 33 scans is needed to achieve a 95% success rate in the qualitative assessment of gastric ultrasound. However, as the risk and severity of aspiration are also influenced by gastric volume, further study concerning quantitative assessment is warranted.', 'detailedDescription': 'This study are conducted to affirm the feasibility of ultrasound for the qualitative assessment of gastric content, and determine the reliability of this novel tool in gastric volume measurements when performed by novice gastric sonographers. Two novels in gastric ultrasound learn from online materials, including educational videos and picture library through www.gastricultrasound.org and www.usra.ca. 1-hour lecture with discussion and 1-hour interactive hands-on with expert in gastric ultrasound. Then the novels were tested for the accuracy and reliability of their skills from 50 volunteers gastric ultrasound assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II\n\nExclusion Criteria:\n\n* BMI \\> 40 kg/m2; pregnancy; diabetes mellitus; a history of upper gastrointestinal tract disease (including hiatal hernia and gastric tumors); and previous surgical procedures on the esophagus, stomach, or upper abdomen.'}, 'identificationModule': {'nctId': 'NCT04760106', 'briefTitle': 'Learning Curves of Gastric Ultrasound for Novel', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Feasibility of Ultrasound for the Qualitative Assessment of Gastric Content, and Determine the Reliability of This Novel Tool in Gastric Volume Measurements When Performed by Novice Gastric Sonographers', 'orgStudyIdInfo': {'id': 'Si 830/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gastric ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'For the qualitative assessment, every participant was scanned once by both examiners. Each scan session lasted no longer than 5 minutes to mitigate the confounding effect of gastric emptying time.\n\nFor the quantitative assessment, the participants were put in a right lateral decubitus position and the antral cross-sectional area (CSA) is measured in the sagittal plane.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'CONTACT', 'email': 'pawinee141@gmail.com', 'phone': '66864001721'}, {'name': 'Pawinee Pangthipampai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'CONTACT', 'email': 'pawinee141@gmail.com', 'phone': '+66864001721'}], 'overallOfficials': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}