Acute Respiratory Failure (ARF)NCT07379242
Lung Recruitment Assessed by 2D/3D-EIT and R/I Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation
An observational study of Acute Respiratory Failure (ARF), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this observational study is to assess the differences and consistency in evaluating lung recruitment potential between the recruitment-to-inflation ratio (R/I ratio) and three-dimensional electrical impedance tomography (3D-EIT) and two-dimensional EIT (2D-EIT) in mechanically ventilated patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (ARF)
- What is being tested?
- The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EIT
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Sep 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 acute respiratory failure who are intubated, under sedation and analgesia with controlled ventilation and no spontaneous breathing will be recruited from the Department of Critical Care Medicine, Peking Union Medical College Hospital. Additional inclusion criteria include an oxygenation index of less than 300 mmHg, clinical judgment indicating the need for PEEP titration, and no contraindications to PEEP titration or EIT examination.
Who may be able to join
- Mechanically ventilated patients under sedation and analgesia with no spontaneous breathing.
- Oxygenation index < 300 mmHg.
- Patients who are clinically judged by the attending doctor to require the PEEP titration.
Who cannot join
- Aged under 18 years.
- Pregnancy.
- Contraindications for EIT examination (e.g. automatic implantable cardioverter defibrillator, implantable pumps, chest wounds limiting electrode belt placement, severe thoracic deformity, and others).
- No informed consent obtained.
- Hemodynamic instability with intolerance to high PEEP levels determined by the attending doctor.
- High-risk populations with pneumothorax, mediastinal emphysema, and other such conditions determined by the attending doctor.
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
Huaiwu He, 010-6915-2300, tjmuhhw@126.com
About this study
Official title: Lung Recruitment Assessed by Two-Dimensional/Three-Dimensional Electrical Impedance Tomography and Recruitment-to-Inflation Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation
The purpose of this observational study is to assess the differences and consistency in evaluating lung recruitment potential between the recruitment-to-inflation ratio (R/I ratio) and three-dimensional electrical impedance tomography (3D-EIT) and two-dimensional EIT (2D-EIT) in mechanically ventilated patients with acute respiratory failure. The main questions it aims to answer is:
Are the lung recruitment potentials predicted by 3D-EIT, 2D-EIT and the R/I ratio consistent? Participants will: Undergo a standardized PEEP titration protocol with synchronized EIT monitoring; Have R/I ratios measured at high and low PEEP levels.
- Conditions
- Acute Respiratory Failure (ARF)
- Being tested
- The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EIT
- Keywords
- Acute respiratory failure, PEEP titration, 3D-EIT, 2D-EIT, Lung recruitability, R/I ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EITDiagnostic test
The patient will undergo a standardized PEEP titration procedure and determination of the Recruitment-to-Inflation ratio (R/I ratio), with concurrent monitoring by both 2D- and 3D- EIT.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patients with hypoxemia requiring clinical PEEP optimization | The study will enroll mechanically ventilated patients under sedation/analgesia without spontaneous breathing, exhibiting a oxygenation index (PaO₂/FiO₂ ratio) <300 mmHg, and deemed clinically eligible for PEEP titration by attending physicians. Receives: Diagnostic Test: The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung recruitment assessed by R/I ratio and 2D/3D-EIT （PEEP titration）
Lung recruitment potential can be predicted by the R/I ratio and the lung collapse rate calculated from 2D/3D-EIT.
Measured: Within 24 hours post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaiwu He, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379242
- Sponsor's protocol ID
- 3D EIT-based PEEP & R/I ratio
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Recruitment Assessed by Two-Dimensional/Three-Dimensional Electrical Impedance Tomography and Recruitment-to-Inflation Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07379242
- Acronym / sponsor ID
- 3D EIT-based PEEP & R/I ratio
- Conditions
- Acute Respiratory Failure (ARF)
- Keywords
- Acute respiratory failure, PEEP titration, 3D-EIT, 2D-EIT, Lung recruitability, R/I ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 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.
The purpose of this observational study is to assess the differences and consistency in evaluating lung recruitment potential between the recruitment-to-inflation ratio (R/I ratio) and three-dimensional electrical impedance tomography (3D-EIT) and two-dimensional EIT (2D-EIT) in mechanically ventilated patients with acute respiratory failure. The main questions it aims to answer is:
Are the lung recruitment potentials predicted by 3D-EIT, 2D-EIT and the R/I ratio consistent? Participants will: Undergo a standardized PEEP titration protocol with synchronized EIT monitoring; Have R/I ratios measured at high and low PEEP levels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients with hypoxemia requiring clinical PEEP optimization | – | Diagnostic Test: The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EITThe study will enroll mechanically ventilated patients under sedation/analgesia without spontaneous breathing, exhibiting a oxygenation index (PaO₂/FiO₂ ratio) <300 mmHg, and deemed clinically eligible for PEEP titration by attending physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory failure who are intubated, under sedation and analgesia with controlled ventilation and no spontaneous breathing will be recruited from the Department of Critical Care Medicine, Peking Union Medical College Hospital. Additional inclusion criteria include an oxygenation index of less than 300 mmHg, clinical judgment indicating the need for PEEP titration, and no contraindications to PEEP titration or EIT examination.
Key inclusion criteria (3 listed)
- Mechanically ventilated patients under sedation and analgesia with no spontaneous breathing.
- Oxygenation index < 300 mmHg.
- Patients who are clinically judged by the attending doctor to require the PEEP titration.
Key exclusion criteria (6 listed)
- Aged under 18 years.
- Pregnancy.
- Contraindications for EIT examination (e.g. automatic implantable cardioverter defibrillator, implantable pumps, chest wounds limiting electrode belt placement, severe thoracic deformity, and others).
- No informed consent obtained.
- Hemodynamic instability with intolerance to high PEEP levels determined by the attending doctor.
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 |
|---|---|---|
| The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EITThe patient will undergo a standardized PEEP titration procedure and determination of the Recruitment-to-Inflation ratio (R/I ratio), with concurrent monitoring by both 2D- and 3D- EIT. | Diagnostic test | Mechanically ventilated patients with hypoxemia requiring clinical PEEP optimization |
Primary outcome
Lung recruitment assessed by R/I ratio and 2D/3D-EIT （PEEP titration）
Time frame: Within 24 hours post-enrollment
Lung recruitment potential can be predicted by the R/I ratio and the lung collapse rate calculated from 2D/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 30 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Huaiwu He study chair
Peking Union Medical College Hospital
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 Acute Respiratory Failure (ARF), 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 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: looking for participants now, as of the sponsor's last update on 30 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 (010-6915-2300, tjmuhhw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung recruitment assessed by R/I ratio and 2D/3D-EIT （PEEP titration） (time frame: Within 24 hours post-enrollment). 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 30 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.