Lung PerfusionNCT07303972
Effects of Inspiratory vs Expiratory Breath-Hold on Lung Perfusion Measured by EIT Saline Indicator Method: A Self-Controlled Study
A study testing Electrical Impedance Tomography Saline Indicator Procedure and Electrical Impedance Tomography Device in people with Lung Perfusion and Respiratory Physiology, run by Shanghai Zhongshan Hospital.
Trial summary
This study aims to compare lung perfusion distribution between inspiratory breath-hold and expiratory breath-hold phases using the saline indicator method combined with electrical impedance tomography (EIT). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Perfusion, Respiratory Physiology, Electrical Impedance Tomography
- What is being tested?
- Electrical Impedance Tomography Saline Indicator Procedure and Electrical Impedance Tomography Device
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Able to provide written informed consent
- Able to perform standardized inspiratory and expiratory breath-hold maneuvers for at least 8 seconds
- No known acute cardiopulmonary disease
- Suitable for noninvasive electrical impedance tomography monitoring and intravenous saline administration
Who cannot join
- Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, severe pulmonary hypertension, or heart failure)
- Hemodynamic instability or clinically significant cardiac arrhythmia
- Contraindication to intravenous saline administration or fluid bolus
- Pregnancy or breastfeeding
- Skin conditions or chest wall abnormalities preventing proper placement of EIT electrodes
About this study
Official title: Electrical Impedance Tomography Saline Indicator Technique for Assessing Differences in Lung Perfusion Between Inspiratory and Expiratory Breath-Hold Phases: A Prospective Self-Controlled Study
This study aims to compare lung perfusion distribution between inspiratory breath-hold and expiratory breath-hold phases using the saline indicator method combined with electrical impedance tomography (EIT). A self-controlled crossover design will be used in which each participant undergoes both breath-hold conditions with standardized rapid intravenous saline injections. The primary objective is to evaluate changes in global and regional pulmonary perfusion under different lung volume states. The findings may improve understanding of perfusion redistribution with lung inflation and support optimized ventilatory strategies in clinical practice.
Read the detailed description
Electrical impedance tomography (EIT) with saline bolus injection is a noninvasive technique capable of generating real-time regional lung perfusion images based on transient impedance changes. Lung perfusion is highly dependent on lung volume, vascular resistance, and gravity, yet quantitative bedside evaluation remains limited.
This prospective self-controlled study investigates the differences in lung perfusion between inspiratory breath-hold (near total lung capacity) and expiratory breath-hold (near functional residual capacity). Each participant will undergo two standardized procedures: (1) expiratory breath-hold followed by a rapid intravenous injection of saline, and (2) inspiratory breath-hold followed by the same injection protocol. The order will be randomized.
Perfusion images will be reconstructed using time-impedance curves derived from saline indicator dilution. Regional perfusion parameters, including dependent vs nondependent zones and global perfusion distribution, will be compared between the two phases.
This study may provide foundational physiological evidence for understanding perfusion redistribution across lung volumes and support the clinical application of EIT in respiratory monitoring, ventilatory management, and rehabilitation in critically ill patients.
- Conditions
- Lung Perfusion, Respiratory Physiology, Electrical Impedance Tomography, Ventilation-Perfusion Mismatch
- Being tested
- Electrical Impedance Tomography Saline Indicator Procedure, Electrical Impedance Tomography Device
- Keywords
- Electrical Impedance Tomography, Lung Perfusion, Saline Indicator, Breath-Hold, Inspiratory / Expiratory Phases, Regional Perfusion, Ventilation-Perfusion Matching
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Tomography Saline Indicator ProcedureProcedure or surgery
Participants undergo continuous electrical impedance tomography (EIT) monitoring with a circumferential electrode belt placed around the thorax. During the procedure, participants perform standardized inspiratory and expiratory breath-hold maneuvers. At each breath-hold phase, a rapid intravenous bolus of sterile saline (10-20 mL) is administered, followed by a saline flush, to generate transient impedance changes for lung perfusion imaging using the saline indicator technique. EIT data are recorded continuously before, during, and after each saline injection. Each participant undergoes both breath-hold conditions and serves as their own control.
Electrical Impedance Tomography DeviceDevice
An FDA-cleared electrical impedance tomography (EIT) device is used to noninvasively monitor thoracic impedance changes during the study procedures. The device is used solely for physiological monitoring and image acquisition and is not being evaluated for safety, performance, or a new indication.
| Study group | Role | What they receive |
|---|---|---|
| Single Group - Self-Controlled | Experimental | Not described Receives: Procedure: Electrical Impedance Tomography Saline Indicator Procedure; Device: Electrical Impedance Tomography Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Lung Perfusion Distribution
Quantitative assessment of global lung perfusion distribution derived from saline-induced impedance changes measured by electrical impedance tomography during inspiratory and expiratory breath-hold phases. Global perfusion is expressed as the percentage contribution of regional perfusion relative to total lung perfusion.
Measured: During the study procedure (within 1 hour)
Secondary outcomes (1)
Global Lung Perfusion Heterogeneity Index
Spatial heterogeneity of lung perfusion quantified using a perfusion heterogeneity index derived from regional perfusion maps obtained with the electrical impedance tomography saline indicator technique.
Measured: During the study procedure (within 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung PerfusionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303972
- Sponsor's protocol ID
- EIT-BH-PERF-2025-01
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography Saline Indicator Technique for Assessing Differences in Lung Perfusion Between Inspiratory and Expiratory Breath-Hold Phases: A Prospective Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07303972
- Acronym / sponsor ID
- EIT-BH-PERF-2025-01
- Conditions
- Lung Perfusion, Respiratory Physiology, Electrical Impedance Tomography, Ventilation-Perfusion Mismatch
- Keywords
- Electrical Impedance Tomography, Lung Perfusion, Saline Indicator, Breath-Hold, Inspiratory / Expiratory Phases, Regional Perfusion, Ventilation-Perfusion Matching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Dec 2025 (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.
This study aims to compare lung perfusion distribution between inspiratory breath-hold and expiratory breath-hold phases using the saline indicator method combined with electrical impedance tomography (EIT). A self-controlled crossover design will be used in which each participant undergoes both breath-hold conditions with standardized rapid intravenous saline injections. The primary objective is to evaluate changes in global and regional pulmonary perfusion under different lung volume states. The findings may improve understanding of perfusion redistribution with lung inflation and support optimized ventilatory strategies in clinical practice.
Detailed description
Electrical impedance tomography (EIT) with saline bolus injection is a noninvasive technique capable of generating real-time regional lung perfusion images based on transient impedance changes. Lung perfusion is highly dependent on lung volume, vascular resistance, and gravity, yet quantitative bedside evaluation remains limited.
This prospective self-controlled study investigates the differences in lung perfusion between inspiratory breath-hold (near total lung capacity) and expiratory breath-hold (near functional residual capacity). Each participant will undergo two standardized procedures: (1) expiratory breath-hold followed by a rapid intravenous injection of saline, and (2) inspiratory breath-hold followed by the same injection protocol. The order will be randomized.
Perfusion images will be reconstructed using time-impedance curves derived from saline indicator dilution. Regional perfusion parameters, including dependent vs nondependent zones and global perfusion distribution, will be compared between the two phases.
This study may provide foundational physiological evidence for understanding perfusion redistribution across lung volumes and support the clinical application of EIT in respiratory monitoring, ventilatory management, and rehabilitation in critically ill patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group - Self-Controlled | Experimental | Procedure: Electrical Impedance Tomography Saline Indicator Procedure, Device: Electrical Impedance Tomography Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Able to provide written informed consent
- Able to perform standardized inspiratory and expiratory breath-hold maneuvers for at least 8 seconds
- No known acute cardiopulmonary disease
- Suitable for noninvasive electrical impedance tomography monitoring and intravenous saline administration
Key exclusion criteria (5 listed)
- Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, severe pulmonary hypertension, or heart failure)
- Hemodynamic instability or clinically significant cardiac arrhythmia
- Contraindication to intravenous saline administration or fluid bolus
- Pregnancy or breastfeeding
- Skin conditions or chest wall abnormalities preventing proper placement of EIT electrodes
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 |
|---|---|---|
| Electrical Impedance Tomography Saline Indicator ProcedureParticipants undergo continuous electrical impedance tomography (EIT) monitoring with a circumferential electrode belt placed around the thorax. During the procedure, participants perform standardized inspiratory and expiratory breath-hold maneuvers. At each breath-hold phase, a rapid intravenous bolus of sterile saline (10-20 mL) is administered, followed by a saline flush, to generate transient impedance changes for lung perfusion imaging using the saline indicator technique. EIT data are recorded continuously before, during, and after each saline injection. Each participant undergoes both breath-hold conditions and serves as their own control. | Procedure or surgery | Single Group - Self-Controlled |
| Electrical Impedance Tomography DeviceAn FDA-cleared electrical impedance tomography (EIT) device is used to noninvasively monitor thoracic impedance changes during the study procedures. The device is used solely for physiological monitoring and image acquisition and is not being evaluated for safety, performance, or a new indication. | Device | Single Group - Self-Controlled |
Primary outcome
Global Lung Perfusion Distribution
Time frame: During the study procedure (within 1 hour)
Quantitative assessment of global lung perfusion distribution derived from saline-induced impedance changes measured by electrical impedance tomography during inspiratory and expiratory breath-hold phases. Global perfusion is expressed as the percentage contribution of regional perfusion relative to total lung perfusion.
1 secondary outcome
Global Lung Perfusion Heterogeneity Index
Time frame: During the study procedure (within 1 hour)
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 26 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography Saline Indicator Procedure and Electrical Impedance Tomography Device in people with Lung Perfusion and Respiratory Physiology, run by Shanghai Zhongshan Hospital.
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 5 inclusion and 5 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Lung Perfusion Distribution (time frame: During the study procedure (within 1 hour)). 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 26 Dec 2025.