Assessment of LVOT VTI in Healthy Volunteers

Reproducibility, Intra- and Inter-Observer Variability of Bedside Cardiac Ultrasound Measurements in the Assessment of Hemodynamic Parameters in Healthy Volunteers

Healthy subjects will have transthoracic echocardiography evaluation of Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) performed by operators after brief training.

Study Overview

• Status: Recruiting
• Conditions: Point of Care Ultrasound (POCUS); Hemodynamic Assessment; Bedside Ultrasonography
• Intervention / Treatment: Other: transthoracic echocardiography

Detailed Description

VTI is an echocardiographic parameter used to assess a patient's hemodynamic status. VTI reflects the distance traveled by blood ejected from the left ventricle during systole, enabling non-invasive estimation of key circulatory parameters, including stroke volume (SV) and cardiac output (CO).

Evidence suggests that even brief training combined with expert supervision allows novice operators to obtain measurements comparable to those of experienced clinicians, indicating a steep learning curve.

In this study, operators with minimal training will perform transthoracic echocardiography and measure LVOT VTI (in cm) in healthy volunteers. These measurements will subsequently be compared with those obtained by an experienced operator.

Aim: To assess the equivalence of LVOT VTI measurements obtained by minimally trained operators compared with those acquired by expert operators, as well as to evaluate inter-operator variability among participants. The findings may support the development and optimization of training programs for physicians in point-of-care echocardiography.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Medical University of Warsaw
    • Contact: Medical University of Warsaw; Phone Number: 48 22 599 2002; Email: julia.mazurek@uckwum.pl
    • Contact: Julia Trzebicka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers without known structural heart disease, no history of atrial fibrillation, no aortic valve disease, and not pregnant.

Description

Inclusion Criteria:

• Age > 18 years,
• Medical student at Medical University of Warsaw or licensed physician.

Exclusion Criteria:

• Age < 18 years,
• Prior experience in performing cardiac ultrasound examinations, including acquisition of apical five- and three-chamber views and Doppler measurements of LVOT VTI.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operator without experience in cardiac ultrasound examinations; Medical student at Medical University of Warsaw or licensed physician	Other: transthoracic echocardiography; After brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator.	Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows.	Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.	Day 2
Assessment of intra-observer variability (intra-operator variability) of VTI measurements.	Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.	Day 2
Assessment of time required to obtain a VTI measurement by participants.	Time (in minutes and seconds) from probe placement to successful acquisition of a valid VTI measurement.	Day 2

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Julia Trzebicka, MD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Critical care; Point of care ultrasound; Bedside Ultrasonography; Hemodynamic Assessment; Velocity-Time Integral
• Other Study ID Numbers: KB/75/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No