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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 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.

Первичные конечные точки

• Percentage of participants with IVC max >2.1 cm and IVC CI <50% in the SC view [Срок оценки: These assessments will take place on the same day; the study visit will last about 60 minutes]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Швейцария · 1 центр

• University Hospital Basel, Endocrinology, Diabetes and Metabolism — Basel

Идентификаторы

NCT: NCT07419048 · 2025-02478; kt26Potasso

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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