- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07600931
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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
-
Warsaw, Polen
- Rekrytering
- Medical University of Warsaw
-
Kontakt:
- Medical University of Warsaw
- Telefonnummer: 48 22 599 2002
- E-post: julia.mazurek@uckwum.pl
-
Kontakt:
- Julia Trzebicka
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Operator without experience in cardiac ultrasound examinations
Medical student at Medical University of Warsaw or licensed physician
|
After brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator.
Tidsram: Day 2
|
Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.
|
Day 2
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows.
Tidsram: Day 2
|
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.
Tidsram: Day 2
|
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.
Tidsram: Day 2
|
Time (in minutes and seconds) from probe placement to successful acquisition of a valid VTI measurement.
|
Day 2
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Julia Trzebicka, MD, Medical University of Warsaw
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- KB/75/2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .