Pre-Hospital Lung Ultrasound Impact on Diagnosis

NCT05461547 | Suspended FDA Device

• 1 other identifier: 15954
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Acute heart failure (AHF) is a major reason patients seek emergency care and is a significant public health burden. The ability to differentiate AHF from other etiologies of dyspnea remains a challenge as symptoms and physical exam findings overlap, especially in the pre-hospital setting where diagnostic tools are not readily available. The inability to differentiate AHF from other causes of dyspnea leads to misdiagnosis, delays in diagnosis, and ultimately delays in appropriate treatment. Delays in initiating HF therapies is associated with poor outcomes including higher rates of in-hospital mortality and longer hospital length of stay. Optimizing treatment for AHF in the pre-hospital setting is associated with increased survival and lower rates of hospital re-admission. Thus, accurate diagnosis and early treatment for AHF in the pre-hospital setting remains a critical unmet need. Lung ultrasound (LUS), through assessment of B-lines, allows for an easy and accurate method for detection of pulmonary congestion seen in AHF patients. Although multiple studies have shown LUS is easy to learn, there is a paucity of data assessing clinical impact of LUS in the pre-hospital setting. The investigators hypothesize that the use of LUS by pre-hospital personnel will improve accuracy for detecting AHF in the pre-hospital setting when compared to usual care (no LUS). Specific Aims: To determine if the use of pre-hospital LUS improves diagnostic accuracy for detecting AHF in patients transported by emergency medical services (EMS) for acute dyspnea when compared to usual care (no LUS).

Conditions

Acute Heart Failure

Keywords

ultrasound; prehospital

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of pre-hospital providers for identifying AHF versus not AHF

  Pre-hospital providers will diagnose AHF or not HF with and without LUS. Diagnostic accuracy will be determined by comparing pre-hospital diagnosis to hospital diagnosis of AHF versus not AHF through independent chart review.

  3 years

Study Arms (2)

Usual Care

OTHER

Other: Usual Care

Lung Ultrasound

EXPERIMENTAL

Diagnostic Test: Lung Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

LUS will be performed and interpreted in real-time to guide acute management.

Lung Ultrasound

Usual Care OTHER

Usual care to decide diagnosis and treatment

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>17yo) with a chief complaint of shortness of breath.

You may not qualify if:

• We will exclude patients with hypotension (SBP \<90), an EKG showing ST-segment elevation, fever \>100.4F, trauma or who are pregnant.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46203, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Emergency Medicine

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: February 9, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)