Clinical trial NCT05025150: Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
Official title: Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma Chest
Pediatric ALL
Keywords: Ultrasonography
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 1020
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Suspected penetration injury to neck, chest or abdomen
* Falls \>10 feet or more than 3 times of the child's height
* Suspected spinal cord injury with neurological deficits
* Pedestrian or cyclist hit or run over by car at \>20mph
* Motor vehicle collision (MVC) at high speed \>50mph or with ejection of occupant
* MVC with death of another occupant or prolonged extrication time or significant intrusion to passenger compartment.
* Crash or flip of motorized vehicle with separation of rider from vehicle
* High voltage electrical injury (\>220V)
* Hanging
* Submersion injury
* Trauma mechanism with cardiac arrest or hypotension adjusted for age
* Explosion injury
* Treating physician discretion on patients otherwise not meeting any of the above criteria

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accuracy of POCUS as compared to chest X-ray in detecting injuries
timeFrame: 7-10 days
Secondary outcomes:
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
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
Study officials:
References: