Artificial Intelligence or Human Hand? A Pilot Study Evaluating Inferior Vena Cava Imaging for Hydration Status - The THAP2 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of participants with IVC max >2.1 cm and IVC CI <50% in the SC view
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 years or older, 50% biological women
排除标准
- •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
结局指标
主要结局
Percentage of participants with IVC max >2.1 cm and IVC CI <50% in the SC view
时间窗: 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.
次要结局
未报告次要终点