RecruitingNCT07419048

Artificial Intelligence or Human Hand? Evaluating Inferior Vena Cava Imaging for Hydration Status

Artificial Intelligence or Human Hand? A Pilot Study Evaluating Inferior Vena Cava Imaging for Hydration Status - The THAP2 Study


Sponsor

University Hospital, Basel, Switzerland

Enrollment

50 participants

Start Date

Feb 2, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This observational pilot project is to compare AI-guided sonographic IVC measurements with those of human operators (experienced sonographer, beginner sonographer) in two commonly used views (Subcostal (SC)), Right Intercostal (RI)) in healthy, euvolemic participants before and after PLR, which mimics hypervolemia, in order to assess the possible role of AI-guided sonographic IVC measurements by assessing its feasibility and reliability. Each participant will undergo a SC and a RI IVC US assessment before and after PLR by both sonographers, resulting in a total of 8 IVC US examinations with 8 additional AI-guided IVC indices assessments.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Part 1 (US assessment in the supine position) and Part 2 (US assessment after PLR) for people with inferior vena cava imaging. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPart 1 (US assessment in the supine position)

IVC US assessment consists of two parts, repeated for both SC and RI views. The IVC is visualized according to either SC or RI view. A video capturing two complete respiratory cycles is recorded in B-mode and stored. Subsequently, the "Smart IVC" preset is selected, and an AI-guided measurement is obtained at the same anatomical point under identical conditions. For each examination, the sonographer places the probe to obtain an optimal assessment point for both human- and AI-guided measurements. The time from examination start to achieving a satisfactory imaging window for both SC view and RI view in the supine position is recorded using a stopwatch.

DIAGNOSTIC_TESTPart 2 (US assessment after PLR)

The participant's legs are elevated to 45° while the upper body remains horizontal (0°). After 2 minutes, the sonographer performs the US assessment following the same protocol as in Part 1. For each examination, the sonographer places the probe to obtain an optimal assessment point for both human- and AI-guided measurements. The time from examination start to achieving a satisfactory imaging window for both SC view and RI view in the supine position is recorded using a stopwatch.


Locations(1)

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, Switzerland

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NCT07419048