ARDSNCT07370610
Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory Distress Syndrome
An observational study of ARDS and Mechanically Ventilated Patients, run by Ruijin Hospital at 1 site in China.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and extensive lung injury. Recent studies indicate that lung functional phenotypes - particularly the distribution and evolution of lung perfusion - may be closely related to patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS, Mechanically Ventilated Patients
- What is being tested?
- EIT Monitoring
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2027
- How long will I take part?
- 28 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARDS Mechanically Ventilated Patients
Who may be able to join
- ge ≥ 18 years
- Moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ ≤ 200 mmHg)
- Mechanically ventilated and eligible for EIT monitoring
- Informed consent obtained from patient or legal surrogate
Who cannot join
- Pregnancy
- Presence of implanted metallic devices interfering with EIT (e.g., pacemaker)
- Severe chest wall deformity or skin condition preventing electrode placement
- Expected survival < 24 hours
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory Distress Syndrome: A Prospective Observational Study
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and extensive lung injury. Recent studies indicate that lung functional phenotypes - particularly the distribution and evolution of lung perfusion - may be closely related to patient outcomes. Electrical impedance tomography (EIT) offers non-invasive, bedside, real-time monitoring of lung perfusion patterns and enables classification into distinct phenotypes and trajectory types over the course of illness. To date, limited data exist on perfusion phenotype trajectories in ARDS patients and their relationship with clinical outcomes. This study seeks to characterize dynamic lung dynamic ventilation-perfusion functional Phenotype using EIT and explore their prognostic significance. Objectives
Primary Objective:
Read more
To identify lung perfusion phenotype trajectories in ARDS patients using EIT and assess their association with 28-day mortality.
Secondary Objectives:
- To determine the relationship between different trajectory types and improvements in oxygenation and respiratory mechanics.
- To investigate how ventilator settings (PEEP, driving pressure) interact with perfusion changes.
- To support individualized mechanical ventilation strategies based on Ventilation-Perfusion Functional Phenotype monitoring
Read the detailed description
Design: Prospective, multicenter, observational cohort study
- Setting: ≥2 tertiary ICUs equipped with EIT capability
- Population: Adult patients with moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ ≤ 200 mmHg) receiving mechanical ventilation
- Intervention: Daily lung perfusion assessment using a 16-electrode EIT belt. Regional ventilation-perfusion (V/Q) ratios are calculated by combining tidal and pulsatile impedance changes. Phenotypes are classified as Matched V/Q, High V/Q (dead space), Low V/Q (shunt), or Globally Impaired V/Q. Trajectories are categorized as Stable, Improving, Deteriorating, or Fluctuating.
- Endpoints:
- Primary: Association between phenotype trajectory type and 28-day mortality
- Secondary: Time to oxygenation improvement, duration of mechanical ventilation, ICU length of stay, interaction between trajectory and ventilator settings
- Conditions
- ARDS, Mechanically Ventilated Patients
- Being tested
- EIT Monitoring
- Keywords
- eit, lung perfusion patterns, Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT MonitoringDevice
- 16-electrode belt positioned around the thorax
- Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change)
- Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration.
- This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio.
| Study group | Role | What they receive |
|---|---|---|
| EIT Monitoring group | * 16-electrode belt positioned around the thorax
* Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change)
* Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration.
* This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio. Receives: Device: EIT Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Measured: From enrollment to 28 days
Secondary outcomes (4)
Time to oxygenation improvement (PaO₂/FiO₂ > 200 mmHg)
Measured: From enrollment until the event occurs, assessed up to 14 days
Duration of mechanical ventilation
Measured: From intubation until successful extubation, assessed up to 28 days or until ICU discharge/death
ICU length of stay
Measured: From ICU admission until discharge from ICU, assessed up to 60 days
Interaction between phenotype trajectory and ventilator settings (PEEP, driving pressure)
Measured: Daily during EIT monitoring period, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongping Qu, Study chair, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370610
- Sponsor's protocol ID
- 20250516
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory Distress Syndrome: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07370610
- Acronym / sponsor ID
- 20250516
- Conditions
- ARDS, Mechanically Ventilated Patients
- Keywords
- eit, lung perfusion patterns, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Jan 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.
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and extensive lung injury. Recent studies indicate that lung functional phenotypes - particularly the distribution and evolution of lung perfusion - may be closely related to patient outcomes. Electrical impedance tomography (EIT) offers non-invasive, bedside, real-time monitoring of lung perfusion patterns and enables classification into distinct phenotypes and trajectory types over the course of illness. To date, limited data exist on perfusion phenotype trajectories in ARDS patients and their relationship with clinical outcomes. This study seeks to characterize dynamic lung dynamic ventilation-perfusion functional Phenotype using EIT and explore their prognostic significance. Objectives
Primary Objective:
To identify lung perfusion phenotype trajectories in ARDS patients using EIT and assess their association with 28-day mortality.
Secondary Objectives:
- To determine the relationship between different trajectory types and improvements in oxygenation and respiratory mechanics.
- To investigate how ventilator settings (PEEP, driving pressure) interact with perfusion changes.
- To support individualized mechanical ventilation strategies based on Ventilation-Perfusion Functional Phenotype monitoring
Detailed description
Design: Prospective, multicenter, observational cohort study
- Setting: ≥2 tertiary ICUs equipped with EIT capability
- Population: Adult patients with moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ ≤ 200 mmHg) receiving mechanical ventilation
- Intervention: Daily lung perfusion assessment using a 16-electrode EIT belt. Regional ventilation-perfusion (V/Q) ratios are calculated by combining tidal and pulsatile impedance changes. Phenotypes are classified as Matched V/Q, High V/Q (dead space), Low V/Q (shunt), or Globally Impaired V/Q. Trajectories are categorized as Stable, Improving, Deteriorating, or Fluctuating.
- Endpoints:
- Primary: Association between phenotype trajectory type and 28-day mortality
- Secondary: Time to oxygenation improvement, duration of mechanical ventilation, ICU length of stay, interaction between trajectory and ventilator settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EIT Monitoring group | – | Device: EIT Monitoring* 16-electrode belt positioned around the thorax * Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change) * Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration. * This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS Mechanically Ventilated Patients
Key inclusion criteria (4 listed)
- ge ≥ 18 years
- Moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ ≤ 200 mmHg)
- Mechanically ventilated and eligible for EIT monitoring
- Informed consent obtained from patient or legal surrogate
Key exclusion criteria (4 listed)
- Pregnancy
- Presence of implanted metallic devices interfering with EIT (e.g., pacemaker)
- Severe chest wall deformity or skin condition preventing electrode placement
- Expected survival < 24 hours
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 |
|---|---|---|
| EIT Monitoring* 16-electrode belt positioned around the thorax * Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change) * Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration. * This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio. | Device | EIT Monitoring group |
Primary outcome
28-day all-cause mortality
Time frame: From enrollment to 28 days
4 secondary outcomes
Time to oxygenation improvement (PaO₂/FiO₂ > 200 mmHg)
Time frame: From enrollment until the event occurs, assessed up to 14 days
Duration of mechanical ventilation
Time frame: From intubation until successful extubation, assessed up to 28 days or until ICU discharge/death
ICU length of stay
Time frame: From ICU admission until discharge from ICU, assessed up to 60 days
Interaction between phenotype trajectory and ventilator settings (PEEP, driving pressure)
Time frame: Daily during EIT monitoring period, up to 14 days
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hongping Qu study chair
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
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 ARDS and Mechanically Ventilated Patients, run by Ruijin Hospital 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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
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?
28-day all-cause mortality (time frame: From enrollment to 28 days). 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 13 Apr 2026.