EIT-Based Pulmonary Perfusion Pulse Wave Versus Swan-Ganz Catheter in Stroke Volume Correlation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume
研究概览
简要总结
The goal of this clinical study is to learn if a new, non-invasive monitoring method called EIT Pulse Wave can accurately measure blood flow to the lungs (pulmonary perfusion) and predict heart stroke volume (SV) in critically ill patients. It will also learn about the safety of this monitoring approach. The main questions it aims to answer are:
How well does the EIT Pulse Wave measurement of lung blood flow correlate with the SV measured by the standard method (Swan-Ganz catheter)? Can we build a reliable model to predict SV non-invasively using the EIT Pulse Wave signal? Researchers will compare the EIT Pulse Wave measurements directly with the Swan-Ganz catheter measurements to see if the new method is accurate.
Participants will:
Be critically ill adults in the ICU who are already receiving mechanical ventilation and have a Swan-Ganz catheter in place for medical reasons.
Undergo simultaneous monitoring using both the EIT device and the Swan-Ganz catheter every 30 minutes for up to 48 hours.
Have their ventilator settings adjusted to different levels as part of the study protocol while both measurements are recorded.
详细描述
Research Overview: Developing a Safer and Simpler Method to Monitor Heart and Lung Function in Critically Ill Patients
- Why are we conducting this study? In the intensive care unit (ICU), doctors need to constantly track subtle changes in patients' heart and lung function, particularly how much blood the heart pumps with each beat (known as "stroke volume") and how blood flows through the lungs (known as "pulmonary perfusion"). This information is crucial for precise medication administration and adjusting ventilator settings.
Currently, the "gold standard" method for measuring stroke volume requires inserting a long, thin catheter (a Swan-Ganz catheter) into a patient's major blood vessel, advancing it near the heart. This is an invasive procedure that carries risks such as infection and bleeding, is expensive, and is technically complex.
Therefore, there is an urgent need to find a non-invasive, safe, and simple method that can continuously and in real-time monitor these critical indicators, much like tracking heart rate or blood pressure. 2. What new method are we testing? We are studying a brand-new technology called "Electrical Impedance Tomography (EIT) Pulse Wave Method." You can think of it as a "smart camera," but instead of using radiation, it uses very weak, safe electrical currents-imperceptible to the human body-to "see" blood flow in the lungs.
The advantages of this technology are significant:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients requiring mechanical ventilation support.
- •Patients meeting the 2023 global ARDS definition and/or shock patients receiving vasoactive medication therapy.
- •Patients who have already had a pulmonary artery catheter inserted due to clinical needs.
排除标准
- •Age under 18 years or over 80 years.
- •Patients with severe obesity (BMI ≥ 35 kg/m²).
- •Pregnant or lactating women.
- •Pulmonary embolism.
- •Patients undergoing ECMO therapy.
- •Arrhythmia.
- •Contraindications to EIT monitoring.
- •Contraindications to pulmonary artery catheter use.
- •Failure to provide signed informed consent.
研究组 & 干预措施
Catheter Cohort
This cohort enrolls all critically ill patients who meet the inclusion criteria, including those requiring mechanical ventilation, meeting the 2023 global ARDS definition and/or being in shock requiring vasoactive drugs, and who have already had a Swan-Ganz catheter inserted for clinical reasons. This study is observational in design and does not impose any additional therapeutic interventions. During the study period, the pulmonary perfusion signals measured by the Electrical Impedance Tomography (EIT) pulse wave method and the actual cardiac stroke volume (SV) data measured by the Swan-Ganz catheter will be recorded synchronously and compared to analyze their correlation and establish a regression model. All monitoring is part of routine medical care based on the patient's clinical condition.
干预措施: Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter (Diagnostic Test)
结局指标
主要结局
Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume
时间窗: From the start of synchronous monitoring for each enrolled subject until the end of the monitoring period (up to 48 hours).
Outcome Measure Title: EIT-derived stroke perfusion signal value, measured via the pulse wave analysis method of Electrical Impedance Tomography (EIT) equipment. Measuring Tool: Electrical Impedance Tomography (EIT) system and its accompanying pulse wave analysis software. Unit of Measure: Relative impedance change units (or Arbitrary Units). Time Point Description: Recorded at each time point synchronized with pulmonary artery catheter measurements, starting from study inclusion, every 30 minutes, for a maximum duration of 48 hours. Primary Outcome Measure 2: Cardiac Stroke Volume Measured by Pulmonary Artery Floating Catheter Outcome Measure Title: Stroke volume, measured via continuous cardiac output monitoring using a pulmonary artery floating catheter (Swan-Ganz catheter). Measuring Tool: Pulmonary artery floating catheter and its accompanying cardiac output monitor. Unit of Measure: Milliliters per beat (mL/beat). Time Point Description: Recorded
次要结局
- Correlation of HPB (EIT) and CO (Swan-Ganz catheter)(at the time of 48 hours after inclusion.)
- Correlation of HPB (EIT) and SV (Swan-Ganz catheter)(at the time of 48 hours after inclusion)
- Correlation between EISV measured by EIT and cardiac output (CO) measured by Swan-Ganz catheter(at the time of 48 hours after inclusion)
- Correlation between EISV measured by EIT and stroke volume (SV) measured by Swan-Ganz catheter(at the time of 48 hours after inclusion)