Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 (SC, 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. US assessment will be performed by two sonographers, one beginner (BS) and one experienced (ES), blinded to each other's measurements. The BS is defined as a doctor who has not performed more than 20 US assessments of the IVC and has not performed clinical US of the abdominal region (at least 1x/week) in the past 6 months. The ES is defined as a doctor who has performed at least 20 US assessments of the IVC and uses US at least 1x/week in the past 6 months. Both BS and ES will perform a 2-hour training session in IVC sonography in two views (SC, RI) with a US-experienced doctor and will have full access to the protocol and measurement techniques during the assessments. The study consists of a screening visit and a study visit, which can be performed on the same day, with at least 2 hours interval between the two.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1 (US assessment in the supine position) | Diagnostic Test | 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. | ||
| Part 2 (US assessment after PLR) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with IVC max >2.1 cm and IVC CI <50% in the SC view | The primary endpoint is to determine the percentage of healthy, euvolemic participants with IVC max >2.1 cm and IVC CI <50% in the SC view when assessed by an ES, by a BS, and by an AI- guided system applied by ES and BS before and after PLR. | These assessments will take place on the same day; the study visit will last about 60 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Recruitment will take place at the University Hospital of Basel through flyers, e-mails, and word of mouth addressed to healthy visitors and employees; ensuring sex neutrality by enrolling 50% biological men and 50% biological women.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Potasso, Dr. med. sc. | Contact | +41 61 328 58 76 | laura.potasso@usb.ch | |
| Anna Vital | Contact | +41 61 55 65 248 | anna.vital@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Laura Potasso, Dr. med. sc. | University Hospital Basel, Endocrinology, Diabetes and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Endocrinology, Diabetes and Metabolism | Recruiting | Basel | 4031 | Switzerland |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2026 | Feb 25, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided