AI versus human-guided inferior vena cava ultrasound for checking hydration
Official title: Artificial Intelligence or Human Hand? A Pilot Study Evaluating Inferior Vena Cava Imaging for Hydration Status - The THAP2 Study
Run by University Hospital, Basel, Switzerland · NCT07419048 · Data updated 2026-11-12
This pilot will test whether an AI tool gives the same IVC ultrasound measurements as an experienced and a beginner sonographer in healthy adults before and after a passive leg raise.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07419048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18 years or older without major cardiac, pulmonary, renal, or liver disease and who are not pregnant or lactating are ideal candidates.
✕Probably not a fit
People with heart failure, arrhythmias, significant valvular disease, recent major cardiovascular events, renal failure, liver cirrhosis, COPD, active volume loss, or those taking diuretics/ACE inhibitors/ARBs are unlikely to benefit from findings generated in this healthy volunteer pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot compares AI-guided IVC measurements with measurements made by a beginner and an experienced sonographer using two common views (subcostal and right intercostal) in healthy, euvolemic adults. Each participant receives ultrasound exams in the supine position and after a passive leg raise to mimic increased intravascular volume, with both sonographers blinded to each other's results. The beginner and experienced sonographers each perform two views before and after the maneuver, and the AI provides parallel indices, yielding eight human exams plus eight AI assessments per participant. The protocol includes a brief standardized training for sonographers and aims to measure feasibility and reliability of AI-derived IVC indices compared with human operators.
Why it matters
Potential benefit: If successful, AI-guided IVC measurements could make bedside hydration checks faster and more consistent, helping clinicians estimate fluid status more reliably.
How similar studies have gone: Previous small studies have shown promising agreement between automated IVC measurement algorithms and expert readers, but results have been variable and the approach remains under investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Laura Potasso, Dr. med. sc. — University Hospital Basel, Endocrinology, Diabetes and Metabolism
- Study coordinator: Laura Potasso, Dr. med. sc.
- Email: laura.potasso@usb.ch
- Phone: +41 61 328 58 76
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.