Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT05272332
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastric Ultrasound Prior to Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in gastric volume before and after 4 hours of fasting', 'timeFrame': 'Over 4 hours', 'description': 'Ultrasound measurement of gastric antrum dimenstions (antero-posterior and cranio-caudal dimensions) before and after 4 hours of fasting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric ultrasound', 'Gastric emptying'], 'conditions': ['Fasting']}, 'descriptionModule': {'briefSummary': 'Serial gastric ultrasound assessments to assess the effect of fasting for 4 hours on gastric volume in mechanically ventilated patients in the ICU fasted for extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients in the ICU who had been on enteral feeding via nasogastric tube, fasted for extubation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age,\n* mechanically ventilated patients in the ICU,\n* intubated with endotracheal\n* enteral feeding for over 6 hours before fasting\n\nExclusion Criteria:\n\n* BMI \\> 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries'}, 'identificationModule': {'nctId': 'NCT05272332', 'briefTitle': 'Gastric Ultrasound Prior to Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Wales Hospital, Shatin, Hong Kong'}, 'officialTitle': 'Serial Ultrasound Assessment of Gastric Volume in Mechanically Ventilated Patients Fasted Prior to Extubation: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'CREC Ref. No. 2020.311'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gastric ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gastric ultrasound upon fasting, after 4 hours, and after nasogastric aspiration, to estimate gastric volume'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Esther Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince of Wales Hospital, Shatin, Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Esther Tang', 'investigatorAffiliation': 'Prince of Wales Hospital, Shatin, Hong Kong'}}}}