Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-02 @ 12:00 PM
Study NCT ID:
NCT05025150
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2021-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1020}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2021-08-21', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of POCUS as compared to chest X-ray in detecting injuries', 'timeFrame': '7-10 days'}], 'secondaryOutcomes': [{'measure': 'Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).', 'timeFrame': '7-10 days'}, {'measure': 'Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).', 'timeFrame': '7-10 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography'], 'conditions': ['Trauma Chest', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'The objective of the proposed study is to investigate the diagnostic accuracy of ED POCUS in pediatric traumatic thoracic injuries including traumatic pneumothorax, hemothorax, lung contusion, rib fractures, and pulmonary edema (from submersion injury). This will be a prospective, multicenter, observational study of children 0-21 years of age presenting to the participating pediatric emergency departments for suspected traumatic thoracic injury. Results of POCUS will be compared to that of chest X-ray, final clinical diagnosis, computed tomography (CT) or magnetic resonance imaging (MRI). Study hypotheses are that POCUS is highly accurate (90-95%) when compared to chest X-ray, and moderately accurate (\\~80%) when compared to CT or MRI in diagnosing these conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "* Suspected penetration injury to neck, chest or abdomen\n* Falls \\>10 feet or more than 3 times of the child's height\n* Suspected spinal cord injury with neurological deficits\n* Pedestrian or cyclist hit or run over by car at \\>20mph\n* Motor vehicle collision (MVC) at high speed \\>50mph or with ejection of occupant\n* MVC with death of another occupant or prolonged extrication time or significant intrusion to passenger compartment.\n* Crash or flip of motorized vehicle with separation of rider from vehicle\n* High voltage electrical injury (\\>220V)\n* Hanging\n* Submersion injury\n* Trauma mechanism with cardiac arrest or hypotension adjusted for age\n* Explosion injury\n* Treating physician discretion on patients otherwise not meeting any of the above criteria", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects will be children 0 to 21 years of age presenting to the participating PEDs meeting trauma activation criteria and with suspected thoracic injury.\n\nExclusion Criteria:\n\n* Congenital or acquired cardiopulmonary or osteogenic conditions rendering POCUS ineffective, foreign body/ barrier to lung ultrasound of which removal is contraindicated, subjects under law-enforcement custody, and subjects deemed unsuitable by treating clinicians.'}, 'identificationModule': {'nctId': 'NCT05025150', 'briefTitle': 'Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Health'}, 'officialTitle': 'Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial', 'orgStudyIdInfo': {'id': '2019.091EXP'}}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Lam, MD', 'role': 'CONTACT'}], 'facility': 'Sutter Medical Center Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Samuel Lam, MD, MPH', 'role': 'CONTACT', 'email': 'docp2slam@gmail.com', 'phone': '916 887 1130'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sutter Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'HIU FUNG SAMUEL LAM', 'investigatorAffiliation': 'Sutter Health'}}}}