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NCT Number: NCT07600931

Assessment of LVOT VTI 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Warsaw

Warsaw, Poland

Location status: Recruiting

Location contact

Julia Trzebicka

CONTACT

Medical University of Warsaw

CONTACT

[email protected]

48 22 599 2002

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Transthoracic Echocardiography

Other

After brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers.

Primary outcomes

  1. Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator.

    Time frame: Day 2

    Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.

Secondary outcomes

  1. Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows.

    Time frame: Day 2

    Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.

  2. Assessment of intra-observer variability (intra-operator variability) of VTI measurements.

    Time frame: Day 2

    Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.

  3. Assessment of time required to obtain a VTI measurement by participants.

    Time frame: Day 2

    Time (in minutes and seconds) from probe placement to successful acquisition of a valid VTI measurement.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

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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