Hemodynamic AssessmentNCT07600931
Assessment of LVOT VTI in Healthy Volunteers
An observational study of Hemodynamic Assessment and Bedside Ultrasonography, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Healthy subjects will have transthoracic echocardiography evaluation of Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) performed by operators after brief training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Assessment, Bedside Ultrasonography, Point of Care Ultrasound (POCUS)
- What is being tested?
- transthoracic echocardiography
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 11 May 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers without known structural heart disease, no history of atrial fibrillation, no aortic valve disease, and not pregnant.
Who may be able to join
- Age > 18 years,
- Medical student at Medical University of Warsaw or licensed physician.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw
Medical University of Warsaw, 48 22 599 2002, julia.mazurek@uckwum.pl
Julia Trzebicka
About this study
Official title: 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.
Read the 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.
- Being tested
- transthoracic echocardiography
- Keywords
- Hemodynamic Assessment, Velocity-Time Integral, Bedside Ultrasonography, Point of care ultrasound, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyOther
After brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Operator without experience in cardiac ultrasound examinations | Medical student at Medical University of Warsaw or licensed physician Receives: Other: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start11 May 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic AssessmentStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Trzebicka, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600931
- Sponsor's protocol ID
- KB/75/2026
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility, Intra- and Inter-Observer Variability of Bedside Cardiac Ultrasound Measurements in the Assessment of Hemodynamic Parameters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07600931
- Acronym / sponsor ID
- KB/75/2026
- Keywords
- Hemodynamic Assessment, Velocity-Time Integral, Bedside Ultrasonography, Point of care ultrasound, Critical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operator without experience in cardiac ultrasound examinations | – | Other: transthoracic echocardiographyMedical student at Medical University of Warsaw or licensed physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers without known structural heart disease, no history of atrial fibrillation, no aortic valve disease, and not pregnant.
Key inclusion criteria (2 listed)
- Age > 18 years,
- Medical student at Medical University of Warsaw or licensed physician.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiographyAfter brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers. | Other | Operator without experience in cardiac ultrasound examinations |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Trzebicka, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Assessment and Bedside Ultrasonography, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator. (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.