Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function (BES2T)
Primary Purpose
Stroke Volume, Cardiovascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke Volume
Eligibility Criteria
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
Sites / Locations
- The Robert Packer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Healthy Volunteer
ED patient with planned heart echocardiogram
Arm Description
Healthy volunteers over the age of 18 who consent to two ultrasounds.
Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05506059
Brief Title
Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function
Acronym
BES2T
Official Title
"BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Guthrie Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Volume, Cardiovascular Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The doctor's doing the ultrasounds will be blinded to each other's measurements and to the patient's past medical history
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteer
Arm Type
Other
Arm Description
Healthy volunteers over the age of 18 who consent to two ultrasounds.
Arm Title
ED patient with planned heart echocardiogram
Arm Type
Experimental
Arm Description
Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Participants will have ultrasounds of the heart by two different emergency medicine doctors.
Primary Outcome Measure Information:
Title
Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians
Description
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.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.
Description
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)
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dean Licurgo, DO
Phone
570-887-4882
Email
Dean.Licurgo@guthrie.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Rittenberger, MD
Email
Jon.Rittenberger@guthrie.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Licurgo, DO
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Licurgo, DO
Email
Dean.Licurgo@guthrie.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function
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