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Pre-Hospital Lung Ultrasound Impact on Diagnosis

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung Ultrasound
Usual Care
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Heart Failure focused on measuring ultrasound, prehospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>17yo) with a chief complaint of dyspnea and at least one of the following: bilateral lower extremity edema, orthopnea, wheezing or rales on auscultation, tachypnea (RR>20) or hypoxia (oxygen saturation <92%).

Exclusion Criteria:

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

Sites / Locations

  • Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual Care

Lung Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2022
Last Updated
June 19, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05461547
Brief Title
Pre-Hospital Lung Ultrasound Impact on Diagnosis
Official Title
Pre-Hospital Lung Ultrasound Impact on Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Prospective, randomized study using a phased implementation on patients being transported by EMS to the hospital for acute dyspnea. The investigators will include adults (>17yo) with a chief complaint of dyspnea and at least one of the following: bilateral lower extremity edema, orthopnea, wheezing or rales on auscultation, increased work of breathing, tachypnea (RR>20) or hypoxia (oxygen saturation <92%). Patients with fever (>100.4F), systolic blood pressure <90mmHg, those requiring immediate intubation, those found to have ST elevation myocardial infarction on EKG, or pregnant will be excluded. Eligible patients will be enrolled in the pre-hospital setting over a 12-month period. Randomization that will occur at the ambulance level using a stepped wedge cluster randomization trial design. Twenty-six full-time paramedics previously trained in LUS will perform a 2 or 4-view imaging protocol and interpret images in real-time to guide acute management. The diagnosis of AHF on LUS will be defined as bilateral B-lines (>2 B-lines in a zone in each hemi-thorax). A hospital diagnosis of AHF versus not HF will be determined through independent chart review by two blinded physicians and will serve as the criterion standard for final diagnosis. Diagnosis by paramedics, whether LUS was used, and treatment given pre-hospital will be tracked in ESO (an online EMS clinical documentation system). For the primary aim the investigators will compare pre-hospital provider diagnosis to final diagnosis to determine accuracy with and without the use of LUS. Expected Results: The investigators anticipate the use of prehospital LUS will improve diagnostic accuracy for detecting AHF. This pilot study will set the groundwork for future larger studies assessing the clinical impact of prehospital LUS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
ultrasound, prehospital

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Other
Arm Title
Lung Ultrasound
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung Ultrasound
Intervention Description
LUS will be performed and interpreted in real-time to guide acute management.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care to decide diagnosis and treatment
Primary Outcome Measure Information:
Title
Diagnostic accuracy of pre-hospital providers for identifying AHF versus not AHF
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (>17yo) with a chief complaint of shortness of breath. Exclusion Criteria: We will exclude patients with hypotension (SBP <90), an EKG showing ST-segment elevation, fever >100.4F, trauma or who are pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Russell
Phone
(317) 880-3900
Email
framruss@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Liao
Email
markliao@iu.edu
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Russell, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre-Hospital Lung Ultrasound Impact on Diagnosis

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