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Clinical OutcomesNCT05207202

Effect of EIT-guided PEEP Titration on the Prognosis of Patients with Moderate to Severe ARDS

A study testing electrical impedance tomography in people with Clinical Outcomes, run by Southeast University, China at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 18 to 80 years
Conditions the study is for
Clinical Outcomes
What is being tested?
electrical impedance tomography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
5 sitesChina
Study dates
20 Feb 2022to 20 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

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 80 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
  • Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
  • Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
  • Severe neuromuscular disease
Show all 13Show fewer
  • Hemodynamic instability
  • 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
  • Solid organ or hematologic tumors with the expected survival time less than 30 days
  • Participating in other clinical trials within 30 days
  • Pregnancy
  • Refusal to sign the informed consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Department of ICU, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine

    Guangzhou, Guangdong, sonysang999@aliyun.com

  • Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

    Nanjing, Jiangsu, 210000

  • Department of Critical Care Medicine, Zhongshan Hospital of Fudan University

    Shangha, Shangha, 200032

  • Department of Critical Care Medicine, Renji Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

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. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes.

Read the detailed description

This is a prospective, multicenter, single-blind, parallel-group, adaptive randomized controlled trial (RCT) with intention-to-treat analysis which aims to determine the effects of PEEP setting guided by EIT on the clinical outcomes for moderate or severe ARDS patients ventilated with lung protective ventilation strategy. Adult patients with moderate to severe ARDS less than 72 hours after diagnosis will be included in this study. Patients in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas patients in the control group will select PEEP based on the FiO2-PEEP table. Other ventilator parameters will be set according to the ARDSnet strategy. The primary outcome is 28-day mortality. The secondary outcomes include ventilator-free days and shock-free days at day 28, length of ICU and hospital stay, the rate of successful weaning, proportion requiring rescue therapies, compilations, respiratory variables, and Sequential Organ Failure Assessment (SOFA). This study will also perform the interim analysis and subgroup analysis.

Being tested
electrical impedance tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electrical impedance tomographyDevice

    PEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O and then reduced in steps of 2cmH2O from 20 to zero every 2min.

Study groups in NCT05207202
Study groupRoleWhat they receive
EIT-PEEP strategyActive comparatorPatients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial
Receives: Device: electrical impedance tomography
ARDSNet-PEEP strategyActive comparatorPEEP will be set according to the low FiO2-PEEP table to keep the oxygenation goals: SpO2 between 88% and 95%, and PaO2 between 55mmHg and 80mmHg.
Receives: Device: electrical impedance tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day mortality

    mortality in Day 28

    Measured: at day 28

Secondary outcomes (12)

  1. VFDs at day 28

    defined as the number of days between successful weaning from MV and day 28 after study enrollment

    Measured: at day 28

  2. Shock-free days at day 28

    Shock-free days at day 28

    Measured: at day 28

  3. Length of ICU stay

    the survival rate(survival/total) during ICU stay

    Measured: up to 24 months

  4. Length of hospital stay

    the survival rate(survival/total) during hospital stay

    Measured: up to 24 months

  5. The rate of successful weaning

    Proportion of people who are not dependent on ventilator ventilation

    Measured: at day 28

  6. Proportion requiring rescue therapies

    Proportion of people who require rescue therapies

    Measured: day 28

  7. Rate of pneumothorax

    Rate of pneumothorax

    Measured: day 28

  8. driving pressure

    measurement as one index of respiratory compliance at day 0, 1, 2, 3, and 7 from enrollment

    Measured: day 0, day 1, day 2, day 3, day 7

  9. Sequential Organ Failure Assessment (SOFA) score at the time of enrollment

    SOFA range from three to eight. The higher the score, the worse the prognosis

    Measured: at the time of enrollment

  10. Blood pressure at day D1, 2, 3, and 7 from enrollment

    Both systolic and diastolic pressure at day D1, 2, 3, and 7 from enrollment

    Measured: up to 24 months

  11. respiratory rate

    respiratory rate

    Measured: up to 7 days

  12. number of shock and gastrointestinal hemorrhage

    shock, and gastrointestinal hemorrhage

    Measured: day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start20 Feb 2022
  3. Primary completion20 Jul 2023
  4. Study completion20 Jul 2023

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207202
Sponsor's protocol ID
2021010065
Status last verified
Mar 2025
First submitted
15 Dec 2021
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yuan 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

  • Yuan X, Zhang R, Wang Y, Chen D, Chao Y, Xu J, Guo L, Liu A, Xie J, Pan C, Yang Y, Qiu H, Liu L. Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial. Trials. 2023 Apr 11;24(1):266. doi: 10.1186/s13063-023-07280-6.

    PubMed 37041561

Questions about this trial

What is this clinical trial studying?

A study testing electrical impedance tomography in people with Clinical Outcomes, run by Southeast University, China at 5 sites 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 13 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 mortality (time frame: at 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 NCT05207202, 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 20 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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