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OpenTrials
Completed

NCT Number: NCT05506059

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

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

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Key information

Conditions

Stroke Volume Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

Participants will have ultrasounds of the heart by two different emergency medicine doctors.

Primary outcomes

  1. Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians

    Time frame: 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 outcomes

  1. Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Official study title

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

Acronym: BES2T

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2022
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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