Correlation Between EIT-based Pulse Wave Method for Pulmonary Perfusion Monitoring and Pulmonary Artery Catheter-based Stroke Volume Measurement

Condition(s) studied

Investigational drug(s) / intervention(s)

Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter: This study is observational in design and does not impose any therapeutic interventions. The described "intervention" refers to the synchronous data acquisition process performed for research purposes. Specifically, based on routine clinical monitoring, the timing of EIT pulse wave method for pulmonary perfusion monitoring and Swan-Ganz catheter for stroke volume (SV) monitoring is precisely synchronized (to the second), and data from both are recorded for subsequent correlation and regression analysis. All monitoring methods are required for the patient's clinical diagnosis and treatment; the research activity is limited to the synchronous recording and comparison of data.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume — 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

Trial sites (1)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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