Evaluating the Feasibility of Prehospital Lung Ultrasound

April 17, 2026 updated by: Tung-Lin Jesse Yuan, DO, Rutgers, The State University of New Jersey

Evaluating the Feasibility of Prehospital Lung Ultrasound: A Multicenter Pilot Study

The goal of this prospective nonrandomized study is to determine if a lung ultrasound exam improves diagnosis of respiratory distress in patients being treated by Emergency Medical Services. The main question it aims to answer is whether ultrasound use increases likelihood of correctly diagnosing 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School/University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pediatric patients (<18)
  • Traumatic etiology
  • Cardiac arrest at any point prehospitally
  • No ultrasound-trained paramedic involved in patient's care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Patients who receive ultrasound
Diagnostic test: Pulmonary ultrasound
Ultrasound of up to six lung zones (1, 2, and 4) will be obtained. Paramedics will assess for the presence of B lines.
No Intervention: Patients before ultrasound implementation
Patients who meet inclusion criteria but were treated before ultrasound was available
No Intervention: Patients who do not receive ultrasound
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of prehospital diagnoses agreeing with hospital diagnosis
Time Frame: At time of hospital discharge (anticipated average of one week)
Diagnostic accuracy
At time of hospital discharge (anticipated average of one week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival to discharge
Time Frame: At time of hospital discharge (anticipated average one week)
At time of hospital discharge (anticipated average one week)
Whether or not patient is intubated by EMS or during hospital admission, recorded as yes or no
Time Frame: EMS patient encounter to hospital discharge (anticipated average one week)
EMS patient encounter to hospital discharge (anticipated average one week)
Days on ventilator or non-invasive ventilation
Time Frame: Hospital arrival to hospital discharge (anticipated average one week)
Hospital arrival to hospital discharge (anticipated average one week)
Length of stay
Time Frame: Hospital arrival to hospital discharge (anticipated average one week)
Hospital arrival to hospital discharge (anticipated average one week)
Length of ICU stay
Time Frame: Hospital admission to hospital discharge (anticipated average one week)
Hospital admission to hospital discharge (anticipated average one week)
Paramedic ultrasound interpretation accuracy
Time Frame: Enrollment
Comparison between paramedic interpretation (of presence of lung sliding and number of B lines) with physician interpretation
Enrollment
Quality of ultrasound obtained by paramedic
Time Frame: Enrollment
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
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Christiana Care Health Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle Levine, MD, Christiana Care Health Services
  • Principal Investigator: Stephen Carroll, DO, MEd, Christiana Care Health Services
  • Principal Investigator: Tung-Lin Yuan, DO, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2025002161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data that can be linked to individual patients will not be shared due to patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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