AI versus human-guided inferior vena cava ultrasound for checking hydration
Artificial Intelligence or Human Hand? A Pilot Study Evaluating Inferior Vena Cava Imaging for Hydration Status - The THAP2 Study
University Hospital, Basel, Switzerland · NCT07419048
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT07419048 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inferior Vena Cava Imaging, Artificial Intelligence, Beginner Sonographer, Experienced Sonographer, Collapsibility Index, Central Venous Pressure, Inferior Vena Cava, Collapsibility Index of Inferior Vena Cava