Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function

Not Applicable

Completed

• Conditions: Stroke Volume; Cardiovascular Diseases
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT05506059
• Lead Sponsor: The Guthrie Clinic

Brief Summary

The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.

Detailed Description

This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.

The doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Study Start: 2022-09-10
• Primary Completion: 2023-08-11
• Study Completion: 2023-08-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care
• Age 18 or over
• Willing and able to provide informed consent

Exclusion Criteria

• Pediatrics (age <18 years old).
• No cardiac-altering intervention performed between examiners.
• Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.
• Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).
• Female with known pregnancy.
• Prisoner
• Prior cardiac surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ED patient with planned heart echocardiogram	Ultrasound	Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care
Healthy Volunteer	Ultrasound	Healthy volunteers over the age of 18 who consent to two ultrasounds.

Primary Outcome Measures

Name	Time	Method
Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians	During procedure	Two physicians will use the same ultrasound device to measure the E-Point Septal Separation (EPSS) on the same patients. EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. The mean change in EPSS measurements in millimeter will be calculated.

Secondary Outcome Measures

Name	Time	Method
Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.	During procedure	Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram. LVEF (in %) will be estimated from ultrasound using the formula = 75.5 - (2.5 x E-Point Septal Separation in millimeters)

Trial Locations

Locations (1)

The Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States