ARDS (Acute Respiratory Distress Syndrome)NCT06990477
Effect of EIT-guided PEEP in ARDS Patients
A study testing EIT-guided PEEP in people with ARDS (Acute Respiratory Distress Syndrome), run by Southeast University, China at 17 sites in 3 countries.
Trial summary
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- EIT-guided PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 13 Mar 2026to 20 Feb 2030
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years
- Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen [PaO2]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
- Diagnosis of ARDS less than 72 hours
Who cannot join
- Expected to be mechanically ventilated for less than 48 hours
- Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
- Undrained pneumothorax or subcutaneous emphysema
- Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
- Severe neuromuscular disease
- Hemodynamic instability
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- Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
- Severe other organs dysfunction with a low expected survival (7 days) or palliative care
- Severe liver disease (Child-Pugh Score ≥10)
- Pregnancy
- Refusal to sign the informed consent
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
China15 sites, 15 recruiting
- Not yet recruiting
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing
Yan Xu Li, PhD, 010-85231000, 13581851048@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Ling Sang, PhD, 020-81566879, sonysang999@vip.163.com
- Not yet recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Jiangsu, 210009
Le Qing Lin, PhD, 0571-56005600, happylin67@126.com
- Not yet recruiting
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Hangzhou
Qing Hui Ge, PhD, +0571-86006856, gehq@zju.edu.cn
- Not yet recruiting
Second Hospital of Anhui Medical University
Hefei, Anhui
Min Yang, PhD, 0551-65997271, yangmin@ahmu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yang Li, PhD, 0791-8631, liyang092792@126.com
- Recruiting
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
yuan xueyan, MD, +86 83262550, 18826401594@163.com
- Not yet recruiting
People's Hospital of Quzhou
Quzhou, Zhejiang
Qiong Dan Wang, PhD, 0570-885041, sara_good@126.com
- Recruiting
Department of Critical Care Medicine, Zhongshan Hospital of Fudan University
Shanghai, China Mainland, 200000
zhong ming PhD, PhD, 021-64373564, 2324858754@qq.com
- Not yet recruiting
Department of Critical Care Medicine, Renji Hospital
Shanghai, China Mainland, 20000
li zhe Li Zhe, PhD, 021-68383354, 2324858754@qq.com
- Not yet recruiting
Ruijin Hospital Shanghai Jiaotong University School Of Medicine
Shanghai
Ping Hong Qu, PhD, 021-64370045, hongpingqu0412@hotmail.com
- Not yet recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
Qin Dong Shi, PhD, 029-85323186, shiqindong@163.com
- Not yet recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Fen Gui Gan, PhD, 0971-6230899, xzhd1991@163.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 210009
Li Ya Chao, MD, 0516-85806320, chaoyali@126.com
- Not yet recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan
Qiong Wu, PhD, 0371-67690831, wqwws87@sina.com
South Korea1 site, 1 recruiting
- Not yet recruiting
Asan Medical Center
Seoul
Suyeon Lee, 02-3010-7455, lsy5013@amc.seoul.kr
Taiwan1 site, 1 recruiting
- Not yet recruiting
Taichung Veterans General Hospital
Taichung
Cheng Ming Zhan, PhD, 886-4-23592525, mingcheng.chan@gmail.com
About this study
Official title: Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Multicenter Randomized Controlled Trial
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.
- Being tested
- EIT-guided PEEP
- 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.
EIT-guided PEEPDevice
PEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O or to 24cmH2O and then reduced in steps of 2cmH2O from 20 to 4 every 30s.
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided PEEP group | Experimental | Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial Receives: Device: EIT-guided PEEP |
| low PEEP-FiO2 table group | No intervention | PEEP will be set according to the low FiO2-PEEP table to keep the oxygenation goals: SpO2 between 90% and 96%, and PaO2 between 60mmHg and 90mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: mortality in Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start13 Mar 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion20 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
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
- NCT06990477
- Sponsor's protocol ID
- EITVent2
- Status last verified
- Jul 2026
- First submitted
- 18 May 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuan X, Chen D, Chao Y, Zhang R, Guo L, Xie J, Liu S, Zhao Z, Huang Y, Yang Y, Mauri T, Qiu H, Liu L. Effect of Individualized Positive End-Expiratory Pressure Titrated by Electrical Impedance Tomography in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2025 Mar;211(3):418-421. doi: 10.1164/rccm.202411-2112RL. No abstract available.
PubMed 39787604Yuan X, Zhong M, Li Z, Sang L, Huang X, Zhang R, Chen H, Gao Y, Wang Y, Lin Z, Lu S, Yang F, Chen T, Guo L, Xie J, Zhao Z, Huang Y, Yang Y, Mauri T, Qiu H, Liu L; Chi-ARDS Net (Chinese ARDS Research Network). Electrical impedance tomography-guided positive end-expiratory pressure and mortality of patients with the acute respiratory distress syndrome: the EITVent randomized clinical trial. Am J Respir Crit Care Med. 2026 Mar 1;212(3):440-451. doi: 10.1093/ajrccm/aamaf125.
PubMed 41738148
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06990477
- Acronym / sponsor ID
- EITVent2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 20 Feb 2030 (estimated)
- First posted
- 25 May 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.
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-guided PEEP group | Experimental | Device: EIT-guided PEEPPatients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial |
| low PEEP-FiO2 table group | No intervention | –PEEP will be set according to the low FiO2-PEEP table to keep the oxygenation goals: SpO2 between 90% and 96%, and PaO2 between 60mmHg and 90mmHg. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years
- Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen [PaO2]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
- Diagnosis of ARDS less than 72 hours
Key exclusion criteria (11 listed)
- Expected to be mechanically ventilated for less than 48 hours
- Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
- Undrained pneumothorax or subcutaneous emphysema
- Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
- Severe neuromuscular disease
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-guided PEEPPEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O or to 24cmH2O and then reduced in steps of 2cmH2O from 20 to 4 every 30s. | Device | EIT-guided PEEP group |
Primary outcome
28-day mortality
Time frame: mortality in Day 28
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 10 Jul 2026.
- Results publication: PubMed 39787604Yuan X, Chen D, Chao Y, Zhang R, Guo L, Xie J, Liu S, Zhao Z, Huang Y, Yang Y, Mauri T, Qiu H, Liu L. Effect of Individualized Positive End-Expiratory Pressure Titrated by Electrical Impedance Tomography in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2025 Mar;211(3):418-421. doi: 10.1164/rccm.202411-2112RL. No abstract available.
- Results publication: PubMed 41738148Yuan X, Zhong M, Li Z, Sang L, Huang X, Zhang R, Chen H, Gao Y, Wang Y, Lin Z, Lu S, Yang F, Chen T, Guo L, Xie J, Zhao Z, Huang Y, Yang Y, Mauri T, Qiu H, Liu L; Chi-ARDS Net (Chinese ARDS Research Network). Electrical impedance tomography-guided positive end-expiratory pressure and mortality of patients with the acute respiratory distress syndrome: the EITVent randomized clinical trial. Am J Respir Crit Care Med. 2026 Mar 1;212(3):440-451. doi: 10.1093/ajrccm/aamaf125.
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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.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-guided PEEP in people with ARDS (Acute Respiratory Distress Syndrome), run by Southeast University, China at 17 sites in 3 countries.
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 11 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, South Korea, Taiwan. 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 yuan xue yan, MD, MD (+86 83262550, 18826401594@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: mortality in Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06990477, which also lists 2 linked publications.
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 10 Jul 2026.