Trauma ChestNCT05025150
Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
An observational study of Trauma Chest and Pediatric ALL, run by Sutter Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Trauma Chest, Pediatric ALL
- How many people
- 1,020 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2019to 8 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sutter Medical Center Sacramento
Sacramento, California, 95816
Samuel Lam, MD
About this study
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
- Keywords
- Ultrasonography
- Medical subject headings
- Thoracic Injuries, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of POCUS as compared to chest X-ray in detecting injuries
Measured: 7-10 days
Secondary outcomes (2)
Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).
Measured: 7-10 days
Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start11 Aug 2019
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutter Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HIU FUNG SAMUEL LAM, Sutter Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025150
- Sponsor's protocol ID
- 2019.091EXP
- Status last verified
- Nov 2023
- First submitted
- 21 Aug 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
- ClinicalTrials.gov ID
- NCT05025150
- Acronym / sponsor ID
- 2019.091EXP
- Conditions
- Trauma Chest, Pediatric ALL
- Keywords
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Sutter HealthUniversity, hospital or other
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Dec 2025 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of POCUS as compared to chest X-ray in detecting injuries
Time frame: 7-10 days
2 secondary outcomes
Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).
Time frame: 7-10 days
Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Chest and Pediatric ALL, run by Sutter Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Lam, MD, MPH (916 887 1130, docp2slam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of POCUS as compared to chest X-ray in detecting injuries (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.