Inferior Vena Cava ImagingTHAP2NCT07419048
Artificial Intelligence or Human Hand? Evaluating Inferior Vena Cava Imaging for Hydration Status
An observational study of Inferior Vena Cava Imaging, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inferior Vena Cava Imaging
- What is being tested?
- Part 1 (US assessment in the supine position) and Part 2 (US assessment after PLR)
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy adults aged 18 years or older, 50% biological women
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, 4031
Laura Potasso, Dr. med. sc., +41 61 328 58 76, laura.potasso@usb.ch
Anna Vital, +41 61 55 65 248, anna.vital@usb.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Inferior Vena Cava Imaging
- Being tested
- Part 1 (US assessment in the supine position), Part 2 (US assessment after PLR)
- Keywords
- Artificial Intelligence (AI), Beginner Sonographer (BS), Experienced Sonographer (ES), Collapsibility Index (CI), Central Venous Pressure (CVP), Inferior Vena Cava (IVC), Collapsibility Index of Inferior Vena Cava (IVC CI), Maximal Diameter of Inferior Vena Cava (IVC max), Passive Leg Raise (PLR), Ultrasound (US)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: These assessments will take place on the same day; the study visit will last about 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Potasso, Dr. med. sc., Principal investigator, University Hospital Basel, Endocrinology, Diabetes and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419048
- Sponsor's protocol ID
- 2025-02478; kt26Potasso
- Other IDs
- 2025
- Acronym
- THAP2
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence or Human Hand? A Pilot Study Evaluating Inferior Vena Cava Imaging for Hydration Status - The THAP2 Study
- ClinicalTrials.gov ID
- NCT07419048
- Acronym / sponsor ID
- THAP2 / 2025-02478; kt26Potasso
- Conditions
- Inferior Vena Cava Imaging
- Keywords
- Artificial Intelligence (AI), Beginner Sonographer (BS), Experienced Sonographer (ES), Collapsibility Index (CI), Central Venous Pressure (CVP), Inferior Vena Cava (IVC), Collapsibility Index of Inferior Vena Cava (IVC CI), Maximal Diameter of Inferior Vena Cava (IVC max)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy adults aged 18 years or older, 50% biological women
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 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 test | – |
| Part 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Potasso, Dr. med. sc. principal investigator
University Hospital Basel, Endocrinology, Diabetes and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inferior Vena Cava Imaging, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Potasso, Dr. med. sc. (+41 61 328 58 76, laura.potasso@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.