Evaluating the Feasibility of Prehospital Lung Ultrasound

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: Not yet recruiting
• Conditions: Pulmonary Edema; Congestive Heart Failure(CHF)
• Intervention / Treatment: Diagnostic test: Pulmonary ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Blizzard; Phone Number: 609-955-4412; Email: eab318@njms.rutgers.edu
• Study Contact Backup: Name: Andrew Grandin; Phone Number: 6099006518; Email: andrew@grandideas.org

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care/New Castle County EMS
      • Contact: Andrew Grandin; Phone Number: 609-900-6518; Email: andrew.grandin@christianacare.org
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School/University Hospital
      • Contact: Elizabeth Blizzard; Phone Number: 609-955-4412; Email: eab318@njms.rutgers.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percent of prehospital diagnoses agreeing with hospital diagnosis	Diagnostic accuracy	At time of hospital discharge (anticipated average of one week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival to discharge		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		EMS patient encounter to hospital discharge (anticipated average one week)
Days on ventilator or non-invasive ventilation		Hospital arrival to hospital discharge (anticipated average one week)
Length of stay		Hospital arrival to hospital discharge (anticipated average one week)
Length of ICU stay		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	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	Enrollment

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Christiana Care Health Services
• Investigators: 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

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Emergency Medical Services; Congestive Heart Failure; Paramedic; Pulmonary Edema; Pulmonary Ultrasound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Pulmonary Edema
• Other Study ID 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