ShockEIT-Cath CorreNCT07385963
Correlation Between EIT-based Pulse Wave Method for Pulmonary Perfusion Monitoring and Pulmonary Artery Catheter-based Stroke Volume Measurement
An observational study of Shock and Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shock, Acute Respiratory Distress Syndrome
- What is being tested?
- Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 15 Mar 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Contraindications to EIT monitoring.
- Contraindications to pulmonary artery catheter use.
- Failure to provide signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yufeng Wang, 86+15925008174 ext. 02785351606, d202582524@hust.edu.cn
1095244223@qq.com
About this study
Official title: EIT-Based Pulmonary Perfusion Pulse Wave Versus Swan-Ganz Catheter in Stroke Volume Correlation
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.
Read more
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.
Read the detailed description
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.
- What is the core question this study aims to answer? While the EIT Pulse Wave method is technologically advanced, we do not yet know if the "pulmonary perfusion signal" it measures is accurate and reliable. Can the data it captures truly reflect the volume of blood pumped by the heart? This is the goal of our study: to conduct a head-to-head, precise comparison between this new non-invasive method and the traditional invasive "gold standard" method to verify its reliability.
- 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).
- What potential benefits might this study bring? For Future Patients: If the study is successful and proves the EIT Pulse Wave method is reliable, countless future critically ill patients could benefit. They could avoid the pain and risks associated with invasive catheters while receiving more continuous and convenient monitoring of heart and lung function, leading to more precise, individualized treatment.
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.
- Conditions
- Shock, Acute Respiratory Distress Syndrome
- Being tested
- Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter
- Keywords
- Critical Illness, Acute Respiratory Distress Syndrome, Shock, Hemodynamic Monitoring, Electric Impedance, Pulmonary Circulation
- Medical subject headings
- Shock, Respiratory Distress Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Data Acquisition of EIT and Pulmonary Artery CatheterDiagnostic test
Also called This field does not need to be filled as there are no other defined interventions in the study.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the start of synchronous monitoring for each enrolled subject until the end of the monitoring period (up to 48 hours).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the time of 48 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385963
- Sponsor's protocol ID
- EITSV20240717
- Other IDs
- EITSV20240717
- Acronym
- EIT-Cath Corre
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Fujita Y, Kent M, Wisner E, Johnson L, Stern J, Qi L, Boone J, Yamamoto T. Combined Assessment of Pulmonary Ventilation and Perfusion with Single-Energy Computed Tomography and Image Processing. Acad Radiol. 2021 May;28(5):636-646. doi: 10.1016/j.acra.2020.04.004. Epub 2020 Jun 10.
PubMed 32534966Nguyen DT, Jin C, Thiagalingam A, McEwan AL. A review on electrical impedance tomography for pulmonary perfusion imaging. Physiol Meas. 2012 May;33(5):695-706. doi: 10.1088/0967-3334/33/5/695. Epub 2012 Apr 24.
PubMed 22532291Franchineau G, Jonkman AH, Piquilloud L, Yoshida T, Costa E, Roze H, Camporota L, Piraino T, Spinelli E, Combes A, Alcala GC, Amato M, Mauri T, Frerichs I, Brochard LJ, Schmidt M. Electrical Impedance Tomography to Monitor Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2024 Mar 15;209(6):670-682. doi: 10.1164/rccm.202306-1118CI.
PubMed 38127779Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EIT-Based Pulmonary Perfusion Pulse Wave Versus Swan-Ganz Catheter in Stroke Volume Correlation
- ClinicalTrials.gov ID
- NCT07385963
- Acronym / sponsor ID
- EIT-Cath Corre / EITSV20240717
- Conditions
- Shock, Acute Respiratory Distress Syndrome
- Keywords
- Critical Illness, Acute Respiratory Distress Syndrome, Shock, Hemodynamic Monitoring, Electric Impedance, Pulmonary Circulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- What is the core question this study aims to answer? While the EIT Pulse Wave method is technologically advanced, we do not yet know if the "pulmonary perfusion signal" it measures is accurate and reliable. Can the data it captures truly reflect the volume of blood pumped by the heart? This is the goal of our study: to conduct a head-to-head, precise comparison between this new non-invasive method and the traditional invasive "gold standard" method to verify its reliability.
- 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).
- What potential benefits might this study bring? For Future Patients: If the study is successful and proves the EIT Pulse Wave method is reliable, countless future critically ill patients could benefit. They could avoid the pain and risks associated with invasive catheters while receiving more continuous and convenient monitoring of heart and lung function, leading to more precise, individualized treatment.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Cohort | – | Diagnostic Test: Synchronous Data Acquisition of EIT and Pulmonary Artery CatheterThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronous Data Acquisition of EIT and Pulmonary Artery CatheterAlso: This field does not need to be filled as there are no other defined interventions in the study.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. | Diagnostic test | Catheter Cohort |
Primary outcome
Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume
Time frame: 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
4 secondary outcomes
Correlation of HPB (EIT) and CO (Swan-Ganz catheter)
Time frame: at the time of 48 hours after inclusion.
Correlation of HPB (EIT) and SV (Swan-Ganz catheter)
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
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
Time frame: at the time of 48 hours after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Results publication: PubMed 32534966Fujita Y, Kent M, Wisner E, Johnson L, Stern J, Qi L, Boone J, Yamamoto T. Combined Assessment of Pulmonary Ventilation and Perfusion with Single-Energy Computed Tomography and Image Processing. Acad Radiol. 2021 May;28(5):636-646. doi: 10.1016/j.acra.2020.04.004. Epub 2020 Jun 10.
- Results publication: PubMed 22532291Nguyen DT, Jin C, Thiagalingam A, McEwan AL. A review on electrical impedance tomography for pulmonary perfusion imaging. Physiol Meas. 2012 May;33(5):695-706. doi: 10.1088/0967-3334/33/5/695. Epub 2012 Apr 24.
- Results publication: PubMed 38127779Franchineau G, Jonkman AH, Piquilloud L, Yoshida T, Costa E, Roze H, Camporota L, Piraino T, Spinelli E, Combes A, Alcala GC, Amato M, Mauri T, Frerichs I, Brochard LJ, Schmidt M. Electrical Impedance Tomography to Monitor Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2024 Mar 15;209(6):670-682. doi: 10.1164/rccm.202306-1118CI.
- Results publication: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojing Zou (86+15925008174, 1095244223@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between EIT Pulmonary Perfusion Signal and Catheter-measured Stroke Volume (time frame: From the start of synchronous monitoring for each enrolled subject until the end of the monitoring period (up to 48 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385963, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.