Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-12 @ 6:08 PM
Study NCT ID:
NCT04104295
Status:
WITHDRAWN
Last Update Posted:
2021-04-20
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never began.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-16', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct placement of NG tube', 'timeFrame': 'Up to 10 minutes', 'description': 'The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasogastric tube', 'ultrasound'], 'conditions': ['Nasogastric Tube']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).', 'detailedDescription': "Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PICU patient undergoing routine NGT insertion by nursing staff\n\nExclusion Criteria:\n\n* Any contraindication for US probe placement such as skin infection and abdominal wounds.\n* Hemodynamically unstable patients.\n* Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.'}, 'identificationModule': {'nctId': 'NCT04104295', 'briefTitle': 'The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study', 'orgStudyIdInfo': {'id': '2000026488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound following X-ray', 'description': 'An ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results.', 'interventionNames': ['Diagnostic Test: Ultrasound following X-ray']}], 'interventions': [{'name': 'Ultrasound following X-ray', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Ultrasound'], 'description': 'A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.', 'armGroupLabels': ['Ultrasound following X-ray']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eitan Neeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University - MEDPED Critical Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}