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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05025150
Other study ID # 2019.091EXP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 11, 2019
Est. completion date December 8, 2025

Study information

Verified date November 2023
Source Sutter Health
Contact Samuel Lam, MD, MPH
Phone 916 887 1130
Email docp2slam@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1020
Est. completion date December 8, 2025
Est. primary completion date August 8, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 21 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Sutter Medical Center Sacramento Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Sutter Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of POCUS as compared to chest X-ray in detecting injuries 7-10 days
Secondary Compare the accuracy of POCUS to cross sectional imaging (CT or MRI). 7-10 days
Secondary Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed). 7-10 days
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