ARDS (Acute Respiratory Distress Syndrome)NCT07083973
Prone Position Assessed by 3D EIT
An observational study of ARDS (Acute Respiratory Distress Syndrome) and Respiratory Failure, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To investigate global and regional changes in lung ventilation and perfusion induced by prone position in ARDS patients assessed by 3D-EIT. And to investigate the difference between 2D-EIT and 3D-EIT in prone position monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
- What is being tested?
- Prone position
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS on mechanical ventilation
Who may be able to join
- patients on mechanical ventilation.
- Diagnosis of ARDS was based on the Berlin definition
- Patients in need of prone position because of clinical condition
Who cannot join
- Under 18 years of age.
- Pregnant women;
- Ribcage malformation
- Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
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
- Recruiting
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Yun Long, 15201518815, icu_longyun@126.com
About this study
Official title: Prone Position Assessment by 3D EIT in ARDS Patients
To investigate global and regional changes in lung ventilation and perfusion induced by prone position in ARDS patients assessed by 3D-EIT. And to investigate the difference between 2D-EIT and 3D-EIT in prone position monitoring.
- Being tested
- Prone position
- Medical subject headings
- Acute Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionBehavioural
Patients were ventilated based on the ARDS-Net recommendations . Patients were kept in a supine position. The process of lung ventilation and perfusion assessment was as follows:
- PEEP was determined by the attending doctor and was kept the same during the supine and prone period.
- 3D-EIT was used to monitor the ventilation and perfusion of ARDS patients at three timepoints: T1: supine position, T2: prone position at 30min, T3: prone position over 10 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional ventilation monitored by EIT
Using EIT to monitor the regional ventilation during supine and prone position, to monitor the ventilation distribution change.
Measured: 5-10minutes
Regional perfusion monitored by EIT
Using EIT to monitor the regional perfusion during supine and prone position, to monitor the ventilation distribution change.
Measured: 5-10minutes
V/Q monitored by EIT
Ventilation and perfusion monitored by EIT in supine and prone position. To evaluate the V/Q match, deadspace and shunt lung region.
Measured: 5-10minutes
Secondary outcomes (2)
Respiratory system compliance
Monitor the respiratory system compliance during supine and prone position
Measured: 1 day
SpO2
Monitor the SpO2 during supine and prone position
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start31 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Dec 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.
- More trials run by Peking Union Medical College 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083973
- Sponsor's protocol ID
- Prone position by 3D-EIT
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position Assessment by 3D EIT in ARDS Patients
- ClinicalTrials.gov ID
- NCT07083973
- Acronym / sponsor ID
- Prone position by 3D-EIT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 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.
To investigate global and regional changes in lung ventilation and perfusion induced by prone position in ARDS patients assessed by 3D-EIT. And to investigate the difference between 2D-EIT and 3D-EIT in prone position monitoring.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS on mechanical ventilation
Key inclusion criteria (3 listed)
- patients on mechanical ventilation.
- Diagnosis of ARDS was based on the Berlin definition
- Patients in need of prone position because of clinical condition
Key exclusion criteria (4 listed)
- Under 18 years of age.
- Pregnant women;
- Ribcage malformation
- Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
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 |
|---|---|---|
| Prone positionPatients were ventilated based on the ARDS-Net recommendations . Patients were kept in a supine position. The process of lung ventilation and perfusion assessment was as follows: 1. PEEP was determined by the attending doctor and was kept the same during the supine and prone period. 2. 3D-EIT was used to monitor the ventilation and perfusion of ARDS patients at three timepoints: T1: supine position, T2: prone position at 30min, T3: prone position over 10 hours. | Behavioural | – |
Primary outcome
Regional ventilation monitored by EIT
Time frame: 5-10minutes
Using EIT to monitor the regional ventilation during supine and prone position, to monitor the ventilation distribution change.
Regional perfusion monitored by EIT
Time frame: 5-10minutes
Using EIT to monitor the regional perfusion during supine and prone position, to monitor the ventilation distribution change.
V/Q monitored by EIT
Time frame: 5-10minutes
Ventilation and perfusion monitored by EIT in supine and prone position. To evaluate the V/Q match, deadspace and shunt lung region.
2 secondary outcomes
Respiratory system compliance
Time frame: 1 day
SpO2
Time frame: 1 day
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 Jan 2026.
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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 Respiratory Failure, run by Peking Union Medical College 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 3 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: looking for participants now, as of the sponsor's last update on 26 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 Huaiwu He (01069152301, tjmuhhw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional ventilation monitored by EIT (time frame: 5-10minutes). The study lists 3 primary outcomes in all. 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 Jan 2026.