Congestive Heart Failure(CHF)NCT07549334
Evaluating the Use of Prehospital Lung Ultrasound in EMS: A Multicenter Pilot Study
A study testing Pulmonary ultrasound in people with Congestive Heart Failure(CHF) and Pulmonary Edema, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The goal of this prospective nonrandomized study is to determine if prehospital lung ultrasound findings result in a change in patient management. This study will look at how lung ultrasound exam improves diagnosis of respiratory distress in patients being treated by Emergency Medical Services, such as patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure(CHF), Pulmonary Edema
- What is being tested?
- Pulmonary ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient treated by Emergency Medical Services
- Complaint of dyspnea
- At least one of the following:
- Oxygen saturation <94% on room air
- Abnormal lung sounds
- Increased work of breathing
- Pedal edema
- Orthopnea
Who cannot join
- Pediatric patients (<18)
- Traumatic etiology
- Cardiac arrest at any point prehospitally
- No ultrasound-trained paramedic involved in patient's care
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Christiana Care/New Castle County EMS
Newark, Delaware, 19718
Andrew Grandin, 609-900-6518, andrew.grandin@christianacare.org
Rutgers New Jersey Medical School/University Hospital
Newark, New Jersey, 07103
Elizabeth Blizzard, 609-955-4412, eab318@njms.rutgers.edu
About this study
The goal of this prospective nonrandomized study is to determine if prehospital lung ultrasound findings result in a change in patient management. This study will look at how lung ultrasound exam improves diagnosis of respiratory distress in patients being treated by Emergency Medical Services, such as patients with heart failure. Additional questions include:
- How well can paramedics obtain and interpret ultrasound images?
- How does ultrasound use change treatment received by patients?
- How does ultrasound use impact patient outcomes? Participants will receive a lung ultrasound exam, but otherwise receive standard evaluation and care. Patients who receive ultrasound will be compared to those who did not receive ultrasound for logistical reasons and patients from before the use of ultrasound. Ultrasound will not be withheld from any patient for the purposes of the study.
- Conditions
- Congestive Heart Failure(CHF), Pulmonary Edema
- Being tested
- Pulmonary ultrasound
- Keywords
- Ultrasound, Emergency Medical Services, Pulmonary Ultrasound, Pulmonary Edema, Congestive Heart Failure, Paramedic
- Medical subject headings
- Heart Failure, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary ultrasoundDiagnostic test
Ultrasound of up to six lung zones (1, 2, and 4) will be obtained. Paramedics will assess for the presence of B lines.
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive ultrasound | Active comparator | Not described Receives: Diagnostic Test: Pulmonary ultrasound |
| Patients before ultrasound implementation | No intervention | Patients who meet inclusion criteria but were treated before ultrasound was available |
| Patients who do not receive ultrasound | No intervention | Patients who do not receive ultrasound after paramedic training due to factors such as lack of probe availability, clinician decision, refusal, etc. Ultrasound will not be deliberately withheld from any patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency with which prehospital lung ultrasound findings result in a change in patient management by EMS
Frequency of management changes will be compared from before prehospital ultrasound was used to after prehospital ultrasound has been implemented.
Measured: From time of patient encounter to patient handoff at the hospital. (anticipated average of one hour)
Secondary outcomes (8)
Survival to discharge
Measured: At time of hospital discharge (anticipated average one week)
Percent of prehospital diagnoses agreeing with hospital diagnosis
Diagnostic accuracy
Measured: At time of hospital discharge (anticipated average of one week)
Whether or not patient is intubated by EMS or during hospital admission, recorded as yes or no
Measured: EMS patient encounter to hospital discharge (anticipated average one week)
Days on ventilator or non-invasive ventilation
Measured: Hospital arrival to hospital discharge (anticipated average one week)
Length of stay
Measured: Hospital arrival to hospital discharge (anticipated average one week)
Length of ICU stay
Measured: Hospital admission to hospital discharge (anticipated average one week)
Paramedic ultrasound interpretation accuracy
Comparison between paramedic interpretation (of presence of lung sliding and number of B lines) with physician interpretation
Measured: Enrollment
Quality of ultrasound obtained by paramedic
Rating of ultrasound using a five-point scale (1 being no recognizable structures, 5 being criteria met for diagnosis, all structures imaged with excellent image quality and diagnosis completely supported) by physician
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure(CHF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services, Cooper University Health Care, Hackensack Meridian Health
- Responsible party
- Principal investigator, Tung-Lin Jesse Yuan, DO, Rutgers, The State University of New Jersey
- Investigators
- Danielle Levine, MD, Principal investigator, Christiana Care Health ServicesStephen Carroll, DO, MEd, Principal investigator, Christiana Care Health ServicesTung-Lin Yuan, DO, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549334
- Sponsor's protocol ID
- Pro2025002161
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data that can be linked to individual patients will not be shared due to patient confidentiality.