NCT07549334

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 17, 2026

Last Update Submit

April 17, 2026

Conditions

Congestive Heart Failure(CHF)Pulmonary Edema

Keywords

UltrasoundEmergency Medical ServicesPulmonary UltrasoundPulmonary EdemaCongestive Heart FailureParamedic

Outcome Measures

Primary Outcomes (1)

  • Percent of prehospital diagnoses agreeing with hospital diagnosis

    Diagnostic accuracy

    At time of hospital discharge (anticipated average of one week)

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (3)

Patients who receive ultrasound

ACTIVE COMPARATOR
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.

Interventions

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.

Patients who receive ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christiana Care/New Castle County EMS

Newark, Delaware, 19718, United States

Location

Rutgers New Jersey Medical School/University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Heart FailurePulmonary Edema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Blizzard

CONTACT

609-955-4412eab318@njms.rutgers.edu

Andrew Grandin

CONTACT

6099006518andrew@grandideas.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

March 17, 2026

First Posted

April 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations

US(2)