Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 8:15 PM
Study NCT ID:
NCT02239068
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Residual Gastric Fluid Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg', 'timeFrame': 'Approximately 2 hours', 'description': 'Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.'}], 'secondaryOutcomes': [{'measure': 'Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg', 'timeFrame': 'Approximate 2 hours', 'description': 'Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CT, sedation, oral contrast'], 'conditions': ['Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation']}, 'descriptionModule': {'briefSummary': 'Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) \\< 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) \\> 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.', 'detailedDescription': 'The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from the Radiology CT schedule.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled for CT abdomen with contrast and require anesthesia/sedation\n* Subjects must be 1 month to 10 years of age (inclusive)\n* The subject's legally authorized representative has given written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast"}, 'identificationModule': {'nctId': 'NCT02239068', 'briefTitle': 'CT Residual Gastric Fluid Volume', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children', 'orgStudyIdInfo': {'id': '2011-0286'}}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Mohamed Mahmoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}