An observational study in Shock and Acute Respiratory Distress Syndrome, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational
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.
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.
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:
Completely Non-Invasive: It only requires placing a belt with electrodes on the patient's chest, causing no trauma.
Real-Time Bedside Monitoring: The device can be brought to the bedside, providing continuous, dynamic images and data without moving critically ill patients.
Radiation-Free: It poses no risk of radiation exposure to either patients or medical staff.
How will the study be conducted? Study Type: This is an observational study. This means we will not make any additional interventions to the patient's treatment. We will only simultaneously record data measured by both devices at the same time points.
Participants: We will recruit critically ill patients who require a Swan-Ganz catheter for their own medical condition. Their participation will not introduce additional medical risks.
Research Process: After patients consent to join the study, we will initiate the non-invasive EIT monitoring simultaneously with the routine stroke volume measurements taken via the Swan-Ganz catheter. We will pair and compare the data recorded by both devices at identical time points (accurate to the second).
For Medical Progress: This would introduce a revolutionary tool to the field of critical care medicine, advancing the development of "non-invasive monitoring" technologies, and ultimately potentially reducing healthcare costs and improving patient outcomes.
For the Participants Themselves: While participation in this study may not offer direct therapeutic benefits, the intensive data monitoring might provide the medical team with richer physiological information, potentially helping to optimize their current treatment plan.
In summary, this study aims to take the crucial first step: validating a promising non-invasive technology, with the hope of transforming the monitoring methods for critically ill patients in the future, making treatment safer and more precise.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 19 is below the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: 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.
Also known as: This field does not need to be filled as there are no other defined interventions in the study.
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
Time frame: From the start of synchronous monitoring for each enrolled subject until the end of the monitoring period (up to 48 hours).
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.
Time frame: at the time of 48 hours after inclusion.
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.
Time frame: at the time of 48 hours after inclusion
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.
Time frame: at the time of 48 hours after inclusion
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.
Time frame: at the time of 48 hours after inclusion
Plan to share: Undecided — Individual participant data (IPD) will not be shared due to participant privacy and data protection concerns. The datasets contain detailed clinical information that, even after de-identification, could potentially allow for re-identification of individuals given the specific and critical nature of the patient population. Furthermore, a comprehensive data sharing agreement plan has not been established for this study.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →