About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age under 18 years or over 80 years.
Patients with severe obesity (BMI ≥ 35 kg/m²).
Pregnant or lactating women.
Pulmonary embolism.
Trial population
The study population consists of critically ill adult patients admitted to the Intensive Care Unit of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. All participants require mechanical ventilation support and meet either the 2023 global ARDS diagnostic criteria and/or are receiving vasoactive medications for shock treatment. A key inclusion prerequisite is that patients must already have a Swan-Ganz catheter inserted for clinical hemodynamic monitoring purposes. Study subjects will undergo simultaneous non-invasive EIT monitoring and invasive catheter measurements to evaluate the correlation between the two methods in measuring stroke volume.
Trial design
Cohort
Prospective
Treatments tested in this trial
Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter
Diagnostic testThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume
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
Secondary outcomes
Correlation of HPB (EIT) and CO (Swan-Ganz catheter)
Continuous monitoring of patients' HPB values was performed using an EIT device, while cardiac output (CO) was simultaneously measured using a Swan-Ganz catheter. Depending on the distribution of the data (normal or non-normal), Pearson or Spearman correlation analysis was applied to calculate the correlation coefficient and the corresponding P value between HPB and CO.
Correlation of HPB (EIT) and SV (Swan-Ganz catheter)
Continuous monitoring of patients' HPB values was performed using an EIT device, while stroke volume (SV) was simultaneously measured using a Swan-Ganz catheter. Depending on the distribution of the data (normal or non-normal), Pearson or Spearman correlation analysis was applied to calculate the correlation coefficient and the corresponding P value between HPB and SV.
Correlation between EISV measured by EIT and cardiac output (CO) measured by Swan-Ganz catheter
Continuous monitoring of patients' HPB values was performed using an EIT device, while cardiac output (CO) was simultaneously measured using a Swan-Ganz catheter. Depending on the distribution of the data (normal or non-normal), Pearson or Spearman correlation analysis was applied to calculate the correlation coefficient and the corresponding P value between EISV and CO.
Correlation between EISV measured by EIT and stroke volume (SV) measured by Swan-Ganz catheter
Continuous monitoring of patients' HPB values was performed using an EIT device, while stroke volume (SV) was simultaneously measured using a Swan-Ganz catheter. Depending on the distribution of the data (normal or non-normal), Pearson or Spearman correlation analysis was applied to calculate the correlation coefficient and the corresponding P value between EISV and SV.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: