ARDS (Acute Respiratory Distress Syndrome)NCT07327268
Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS
An observational study of ARDS (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), run by Southeast University, China at 1 site in China.
Trial summary
Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Pulmonary Perfusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Aug 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients admitted to our ICU were screened for inclusion and exclusion criteria
Who may be able to join
- Adult patients with mechanical ventilation
- diagnosis of moderate to severe ARDS no more than 72 hours
Who cannot join
- Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease
- Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)
- Undrained pneumothorax or pneumomediastinum,
- Hemodynamic instability
- Pregnancy
- Refusal by family or the attending physician to participate in the study.
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
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
yuan xueyan, MD, +86 83262550, 18826401594@163.com
About this study
Official title: Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS Patients With Mechanical Ventilation
Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution. Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow. However, if 3D-EIT can help to identify "cyclic on-off switching of pulmonary blood flow" is still unclear.
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Pulmonary Perfusion
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| phase 1 | patients ventilated with a tidal volume of 4ml/kg pbw | |
| phase 2 | patients ventilated with a tidal volume of 6ml/kg pbw | |
| phase 3 | patients ventilated with a tidal volume of 8ml/kg pbw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of "Cyclic On-Off Switching"
"Cyclic On-Off Switching" was assessed by 3D-EIT
Measured: 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327268
- Sponsor's protocol ID
- 3D-EIT perfusion
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07327268
- Acronym / sponsor ID
- 3D-EIT perfusion
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Pulmonary Perfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 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.
Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution. Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow. However, if 3D-EIT can help to identify "cyclic on-off switching of pulmonary blood flow" is still unclear.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phase 1 | – | –patients ventilated with a tidal volume of 4ml/kg pbw |
| phase 2 | – | –patients ventilated with a tidal volume of 6ml/kg pbw |
| phase 3 | – | –patients ventilated with a tidal volume of 8ml/kg pbw |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients admitted to our ICU were screened for inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Adult patients with mechanical ventilation
- diagnosis of moderate to severe ARDS no more than 72 hours
Key exclusion criteria (6 listed)
- Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease
- Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)
- Undrained pneumothorax or pneumomediastinum,
- Hemodynamic instability
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percent of "Cyclic On-Off Switching"
Time frame: 15min
"Cyclic On-Off Switching" was assessed by 3D-EIT
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 8 Jan 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.
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 (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), run by Southeast University, China 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 2 inclusion and 6 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 8 Jan 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 ling liu Liu, PhD (+86 83262550, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of "Cyclic On-Off Switching" (time frame: 15min). 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 8 Jan 2026.