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Not yet recruiting NCT07549334

Evaluating the Use of Prehospital Lung Ultrasound in EMS: A Multicenter Pilot Study

No phase Interventional Congestive Heart Failure(CHF) Pulmonary Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary ultrasound.
Who it may be relevant to
Registry conditions: Congestive Heart Failure(CHF), Pulmonary Edema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Frequency with which prehospital lung ultrasound findings result in a change in patient management by EMS [Time frame: From time of patient encounter to patient handoff at the hospital. (anticipated average of one hour)]
Secondary outcome measures (8)
  • Survival to discharge [Time frame: At time of hospital discharge (anticipated average one week)]
  • Percent of prehospital diagnoses agreeing with hospital diagnosis [Time frame: 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 [Time frame: 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)]
  • Length of stay [Time frame: Hospital arrival to hospital discharge (anticipated average one week)]
  • Length of ICU stay [Time frame: Hospital admission to hospital discharge (anticipated average one week)]
  • Paramedic ultrasound interpretation accuracy [Time frame: Enrollment]
  • Quality of ultrasound obtained by paramedic [Time frame: Enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Christiana Care/New Castle County EMS — Newark
  • Rutgers New Jersey Medical School/University Hospital — Newark

Identifiers

NCT: NCT07549334 · Pro2025002161

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗