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ARDS (Acute Respiratory Distress Syndrome)NCT07908368

Pulse Wave vs. Saline Contrast EIT for Pulmonary Perfusion in ARDS

An observational study of ARDS (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Monitoring pulmonary perfusion is crucial in critical care, especially for conditions like ARDS. Electrical Impedance Tomography (EIT) is a valuable, non-invasive tool for real-time bedside monitoring.While well-established for lung ventilation, EIT faces a challenge in perfusion imaging because the related impedance… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
20 participants
Where
1 siteChina
Study dates
22 Dec 2025to 30 Dec 2027
How long will I take part?
1 Day
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: Patients who meet the inclusion and exclusion criteria will undergo both pulse wave and saline bolus EIT monitoring at PEEP levels of 5 and 15 cmH₂O.

Who may be able to join

  • Age: 18-80 years;
  • Endotracheal intubation and mechanical ventilation;
  • Presence of a subclavian or internal jugular venous catheter in place;
  • Diagnosis of ARDS according to the 2023 global ARDS definition.

Who cannot join

  • Age <18 or >80 years;
  • Severe obesity (BMI ≥35 kg/m²);
  • Pregnant or lactating women;
  • Pulmonary diseases: acute asthma exacerbation, COPD, pulmonary fibrosis, pleural effusion, pneumothorax, or pulmonary embolism;
  • Cardiac diseases: arrhythmias, significant valvular regurgitation, or cardiac dysfunction (LVEF <50% or right ventricular dysfunction);
  • Hypernatremia;
  • Receiving ECMO therapy;
  • Failure to provide 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, 1 recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xue Tian, MD, 027-85351606, m202376326@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Pulse Wave Method Versus Saline Contrast Pulmonary Perfusion EIT Imaging for Detecting Pulmonary Perfusion in ARDS Patients: a Prospective Observational Study

Monitoring pulmonary perfusion is crucial in critical care, especially for conditions like ARDS. Electrical Impedance Tomography (EIT) is a valuable, non-invasive tool for real-time bedside monitoring.While well-established for lung ventilation, EIT faces a challenge in perfusion imaging because the related impedance signal is very weak. Currently, two main methods are used:Saline Bolus EIT: Involves injecting a saline solution during a breath-hold to track blood flow.Pulse Wave EIT: Utilizes cardiac-induced vascular pulsations to assess perfusion.However, both methods have limitations in ARDS patients, as the disease's altered physiology can affect their accuracy.

This study compares pulse wave versus saline bolus EIT for pulmonary perfusion assessment in ARDS patients and investigates the impact of different PEEP levels.

Read the detailed description

During clinical diagnosis and treatment, a patient's oxygenation status is not only related to ventilation but also closely associated with pulmonary blood flow perfusion. In many diseases, physicians need to closely monitor patients' pulmonary perfusion function, such as pulmonary embolism (PE), pulmonary hypertension (PH), and acute respiratory distress syndrome (ARDS).

Particularly during mechanical ventilation for ARDS or fluid resuscitation for shock patients, there is an urgent need for bedside, dynamic, non-invasive, continuous, real-time, and visual monitoring of critically ill patients. Simultaneously, understanding the real-time dynamic changes in cardiac and respiratory pathophysiology is essential for implementing individualized, goal-directed precision therapy, improving patient outcomes, and reducing mortality.

Electrical Impedance Tomography (EIT) is an imaging technique that reconstructs images based on the impedance characteristics of biological tissues. Thoracic EIT can non-invasively, real-time, and dynamically monitor changes in pulmonary electrical impedance, capturing impedance images and data that vary with lung ventilation and perfusion. This reflects lung pathology and dynamic processes, holding significant value for the diagnosis and treatment of critically ill patients.

EIT has long been established in the field of lung ventilation and is widely used clinically. However, using EIT for pulmonary perfusion imaging is challenging. The impedance changes caused by pulmonary blood perfusion are less than one-tenth of those caused by ventilation and are easily masked by various types of noise, making them extremely difficult to extract. Currently, there are two main solutions:Injecting a high-conductivity contrast agent, also known as saline bolus EIT imaging or contrast-enhanced EIT imaging;The pulse wave method.

The former is performed by injecting a 3%-20% sodium chloride (NaCl) solution via a catheter during an end-expiratory breath-hold, eliminating respiratory interference. As the saline passes sequentially through the right atrium, right ventricle, and pulmonary artery, it produces a first-pass kinetic dilution effect. The resulting impedance changes reflect forward pulmonary blood flow-regions with rich perfusion exhibit high conductivity, and the collected thoracic impedance data show a decrease. Images are then reconstructed based on the obtained impedance-time curve. However, in moderate to severe ARDS patients, variations in lung compliance and pulmonary vascular resistance may affect perfusion detection during apnea.

The latter method monitors pulmonary perfusion based on the principle that lung blood perfusion coincides with vascular pulsations. Nevertheless, increased pulmonary vascular permeability in ARDS patients may impact the accuracy of pulse wave-based perfusion detection.

This study aims to compare pulse wave EIT and saline bolus EIT for assessing pulmonary perfusion in ARDS patients, and to evaluate the changes in monitoring indices under different PEEP levels.

Medical subject headings
Acute Lung Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary perfusion was assessed using both pulse wave and saline bolus EIT at PEEP levels of 5 and 15 cmH₂O.

    At a PEEP of 5 cmH₂O, pulse wave EIT data were recorded for 3 minutes. Subsequently, during an inspiratory or expiratory hold, a 10 mL bolus of 10% hypertonic saline was administered via the central venous catheter while EIT data were simultaneously recorded for another 3 minutes. This procedure was repeated at a PEEP of 15 cmH₂O. Pulmonary perfusion data were obtained through offline analysis of the EIT data.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

Secondary outcomes (18)
  1. At PEEP 5 cmH₂O and 15 cmH₂O, perform EIT monitoring of pulmonary perfusion during a 15-second inspiratory or expiratory hold.

    At a PEEP of 5 cmH₂O, EIT data were first recorded for 1 minute, followed by a 15-second inspiratory hold, after which data acquisition was continued for an additional 2 minutes. The entire procedure was repeated at a PEEP of 15 cmH₂O. Pulmonary perfusion data were subsequently analyzed using offline software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  2. Under PEEP 5 cmH₂O conditions, EIT data were acquired during bolus injections of either 10 mL of 0.9% saline or 10 mL of 10% hypertonic saline for pulmonary perfusion analysis.

    At a PEEP of 5 cmH₂O, the following protocol was performed: First, EIT data were recorded for 1 minute, followed by a bolus injection of 10 mL of 0.9% saline via the central venous catheter; data acquisition then continued for an additional 2 minutes. Then, the procedure was repeated with a bolus injection of 10 mL of 10% hypertonic saline. Pulmonary perfusion data were subsequently analyzed using offline software.

    Measured: Under a PEEP of 5 cmH₂O, EIT data acquisition was performed after 30 minutes of stable ventilation.

  3. The ventilation-perfusion matching percentage was assessed using both pulse wave and saline bolus EIT at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  4. The ventilation-perfusion matching percentage was monitored by EIT during 15-second inspiratory or expiratory holds at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  5. Under PEEP 5 cmH₂O conditions, EIT data were acquired during bolus injections of either 10 mL of 0.9% saline or 10 mL of 10% hypertonic saline for ventilation-perfusion matching percentage.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under a PEEP of 5 cmH₂O, EIT data acquisition was performed after 30 minutes of stable ventilation.

  6. The dead space percentage was assessed using both pulse wave and saline bolus EIT at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  7. The dead space percentage was monitored by EIT during 15-second inspiratory or expiratory holds at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  8. Under PEEP 5 cmH₂O conditions, the dead space percentage was obtained by EIT monitoring following bolus injections of either 10 mL of 0.9% saline or 10 mL of 10% hypertonic saline.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under PEEP 5 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  9. The shunt percentage was assessed using both pulse wave and saline bolus EIT at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  10. The shunt space percentage was monitored by EIT during 15-second inspiratory or expiratory holds at PEEP levels of 5 and 15 cmH₂O.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  11. Under PEEP 5 cmH₂O conditions, the shunt space percentage was obtained by EIT monitoring following bolus injections of either 10 mL of 0.9% saline or 10 mL of 10% hypertonic saline.

    The ventilation-perfusion matching percentage was derived from EIT images using offline analysis software.

    Measured: Under PEEP 5 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  12. At PEEP 5 cmH₂O, heart rate was monitored: at baseline, during 15-second inspiratory and expiratory holds, following bolus injections of 10 mL of 0.9% saline and 10% hypertonic saline, and during combined breath-hold-and-injection procedures.

    Heart rate was obtained from the patient monitor.

    Measured: Under PEEP 5 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  13. At PEEP 15 cmH₂O, heart rate was monitored: at baseline, during 15-second inspiratory and expiratory holds, and during combined breath-hold-and-injection procedures.

    Heart rate was obtained from the patient monitor.

    Measured: Under PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  14. At PEEP 5 cmH₂O, blood pressure was monitored: at baseline, during 15-second inspiratory and expiratory holds, following bolus injections of 10 mL of 0.9% saline and 10% hypertonic saline, and during combined breath-hold-and-injection procedures.

    Blood pressure was obtained from the patient monitor.

    Measured: Under PEEP 5 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  15. At PEEP 15 cmH₂O, blood pressure was monitored: at baseline, during 15-second inspiratory and expiratory holds, and during combined breath-hold-and-injection procedures.

    Blood pressure was obtained from the patient monitor.

    Measured: Under PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  16. At PEEP 5 cmH₂O, central venous pressure was monitored: at baseline, during 15-second inspiratory and expiratory holds, following bolus injections of 10 mL of 0.9% saline and 10% hypertonic saline, and during combined breath-hold-and-injection procedures

    Central venous pressure was obtained from the patient monitor.

    Measured: Under PEEP 5 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  17. At PEEP 15 cmH₂O, central venous pressure was monitored: at baseline, during 15-second inspiratory and expiratory holds, and during combined breath-hold-and-injection procedures.

    Central venous pressure was obtained from the patient monitor.

    Measured: Under PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.

  18. The PaO₂/FiO₂ ratio was recorded prior to patient enrollment.

    The PaO₂/FiO₂ ratio was obtained from arterial blood gas analysis.

    Measured: Prior to enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start22 Dec 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
20 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07908368
Sponsor's protocol ID
LPEIT20241102
Status last verified
Dec 2025
First submitted
25 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Xue Tian, MD (027-85351606, m202376326@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary perfusion was assessed using both pulse wave and saline bolus EIT at PEEP levels of 5 and 15 cmH₂O. (time frame: Under both PEEP 5 cmH₂O and PEEP 15 cmH₂O conditions, EIT data were acquired after 30 minutes of stable ventilation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Nov 2026.

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