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

NCT07385963 | Not Yet Recruiting DMC

• 1 other identifier: EITSV20240717
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock; Acute Respiratory Distress Syndrome

Keywords

Critical Illness; Acute Respiratory Distress Syndrome; Shock; Hemodynamic Monitoring; Electric Impedance; Pulmonary Circulation

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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

Study Arms (1)

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.

Diagnostic Test: Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter

Interventions

Synchronous Data Acquisition of EIT and Pulmonary Artery Catheter DIAGNOSTIC_TEST

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.

Catheter Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Related Publications (4)

• Fujita Y, Kent M, Wisner E, et al. Combined assessment of pulmonary ventilation and perfusion with single-energy computed tomography and image processing. Acad Radiol,2021, 28:636-646.

  RESULT

• Nguyen DT, Jin C, Thiagalingam A, et al. A review on electrical impedance tomography for pulmonary perfusion imaging. Physiol Meas, 2012, 33(5): 695-706.

  RESULT

• Franchineau G, Jonkman AH, Piquilloud L, et al.Electrical Impedance Tomography to Monitor Hypoxemic Respiratory Failure. Am J Respir Crit Care Med.2024.15;209(6):670-682

  RESULT

• Frerichs I, Amato MBP, Van Kaam AH, et al. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations:Consensus statement of the translational EIT development study group. Thorax, 2017, 72(1):83-93

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

EIT Images and Signal Data: Dynamically sequenced lung perfusion images and raw impedance waveforms collected by the electrical impedance tomography device. Hemodynamic Data: Measurements from the Swan-Ganz catheter synchronized with EIT monitoring, including parameters such as stroke volume. Respiratory Mechanics Data: Parameters recorded during mechanical ventilation, including airway pressure, tidal volume, and PEEP settings. Anonymized Clinical Data: De-identified basic clinical information of patients corresponding to the data mentioned above.

MeSH Terms

Conditions

Shock; Respiratory Distress Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes

Central Study Contacts

Xiaojing Zou

CONTACT

86+15925008174; 1095244223@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: February 4, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

CN (1)