Artificial Intelligence or Human Hand? Evaluating Inferior Vena Cava Imaging for Hydration Status (THAP2)

February 25, 2026 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Endocrinology, Diabetes and Metabolism
        • Contact:
        • Principal Investigator:
          • Laura Potasso, Dr. med. sc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Healthy adults aged 18 years or older, 50% biological women

Exclusion Criteria:

  • Pregnant or lactating women
  • History of thrombosis of the inferior vena cava
  • Major cardiovascular event in the last 3 months
  • History of peripheral arterial disease of the legs
  • History of heart failure of any grade
  • History of atrial fibrillation or atrial flutter
  • History of severe valvular disease
  • History of renal failure
  • History of liver cirrhosis
  • History of chronic obstructive lung disease (COPD), chronic bronchitis, pulmonary emphysema
  • History of diabetes mellitus
  • History of arginine-vasopressin (AVP) disturbance
  • Abdominal surgery within the last 3 month
  • Volume loss (diarrhoea, vomiting, or bleeding) within the past 3 days
  • Respiratory distress of any grade
  • Any diuretic therapy, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs)
  • Inability to follow procedures or insufficient proficiency in the study language
  • Inability to provide informed consent
  • Vital signs outside normal limits: tachycardia >100 bpm, systolic blood pressure <85 mmHg, or SpO2 < 92%
  • Employees or colleagues in a direct supervisory, subordinate, or collaborative relationship with the study team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with IVC max >2.1 cm and IVC CI <50% in the SC view
Time Frame: These assessments will take place on the same day; the study visit will last about 60 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Laura Potasso, Dr. med. sc., University Hospital Basel, Endocrinology, Diabetes and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-02478; kt26Potasso

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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