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

Cardiovascular Diseases Clinical Trial

— BES2T  

Official title:

"BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506059
• Other study ID #: 2206-26
• Status: Completed
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: February 2024
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Emergencies
• Stroke Volume

Intervention

Diagnostic Test:
• Ultrasound
Participants will have ultrasounds of the heart by two different emergency medicine doctors.

Locations

Country	Name	City	State
United States	The Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians	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.	During procedure
Secondary	Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.	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)	During procedure