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

NCT05506059 | Completed

• 1 other identifier: 2206-26
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke Volume; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  During procedure

Study Arms (2)

Healthy Volunteer

OTHER

Healthy volunteers over the age of 18 who consent to two ultrasounds.

Diagnostic Test: Ultrasound

ED patient with planned heart echocardiogram

EXPERIMENTAL

Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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

ED patient with planned heart echocardiogram; Healthy Volunteer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

The Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dean Licurgo, DO

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The doctor's doing the ultrasounds will be blinded to each other's measurements and to the patient's past medical history
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: September 10, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)