- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
-
Warsaw, Polen
- Rekruttering
- Medical University of Warsaw
-
Ta kontakt med:
- Medical University of Warsaw
- Telefonnummer: 48 22 599 2002
- E-post: julia.mazurek@uckwum.pl
-
Ta kontakt med:
- Julia Trzebicka
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator.
Tidsramme: Day 2
|
Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.
|
Day 2
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Day 2
|
Time (in minutes and seconds) from probe placement to successful acquisition of a valid VTI measurement.
|
Day 2
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Julia Trzebicka, MD, Medical University of Warsaw
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- KB/75/2026
Plan for individuelle deltakerdata (IPD)
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