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Recruiting NCT07600931

Assessment of LVOT VTI in Healthy Volunteers

Observational Hemodynamic Assessment Bedside Ultrasonography Point of Care Ultrasound (POCUS)

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transthoracic echocardiography.
Who it may be relevant to
Registry conditions: Hemodynamic Assessment, Bedside Ultrasonography, Point of Care Ultrasound (POCUS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator. [Time frame: Day 2]
Secondary outcome measures (3)
  • Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows. [Time frame: Day 2]
  • Assessment of intra-observer variability (intra-operator variability) of VTI measurements. [Time frame: Day 2]
  • Assessment of time required to obtain a VTI measurement by participants. [Time frame: Day 2]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Medical University of Warsaw — Warsaw

Identifiers

NCT: NCT07600931 · KB/75/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗