Recruiting

Ultrasound

Sponsor:

Sutter Health

Code:

NCT05025150

Conditions

Trauma Chest

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Trauma Chest

Pediatric ALL

Study ID

NCT05025150

Start date

Aug 11, 2019

Status verified date

Nov, 2023

Completion date

Dec 8, 2025

Anticipated

Primary completion date

Aug 8, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1020 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Accuracy of POCUS as compared to chest X-ray in detecting injuries [ Time Frame: 7-10 days ]

Central Contacts and Locations

Central contacts

Samuel Lam, MD, MPH

916 887 1130docp2slam@gmail.com

Locations

Sutter Medical Center Sacramento

Recruiting

Sacramento, California, United States, 95816

More Information

Sponsor

Sutter Health

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Keywords

  • Ultrasonography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sutter Health on 2023-11-28.