Health TrialsbyHealthPanel

Assessment of LVOT VTI in Healthy Volunteers

ConditionsHemodynamic AssessmentBedside UltrasonographyPoint of Care Ultrasound (POCUS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 18 years,

Medical student at Medical University of Warsaw or licensed physician.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • transthoracic echocardiography

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Operator without experience in cardiac ultrasound examinations1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 2

Secondary outcomes

1

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.

Time frame
Day 2
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.

Time frame
Day 2
3

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.

Time frame
Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Warsaw

Lead sponsor

Source ClinicalTrials.gov
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