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NCT Number: NCT07419048

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this 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 (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Vital

CONTACT

[email protected]

+41 61 55 65 248

Laura Potasso, Dr. med. sc.

CONTACT

[email protected]

+41 61 328 58 76

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: THAP2

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.