NCT06990477

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Feb 2030

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2030

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

May 18, 2025

Last Update Submit

July 9, 2026

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    mortality in Day 28

Study Arms (2)

EIT-guided PEEP group

EXPERIMENTAL

Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial

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.

Interventions

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.

EIT-guided PEEP group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Second Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Department of Critical Care Medicine, Zhongshan Hospital of Fudan University

Shanghai, China Mainland, 200000, China

RECRUITING

Department of Critical Care Medicine, Renji Hospital

Shanghai, China Mainland, 20000, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Jiangsu, 210009, China

NOT YET RECRUITING

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 210009, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, China

NOT YET RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

NOT YET RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, China

NOT YET RECRUITING

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, China

NOT YET RECRUITING

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

Hangzhou, China

NOT YET RECRUITING

Ruijin Hospital Shanghai Jiaotong University School Of Medicine

Shanghai, China

NOT YET RECRUITING

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 39787604RESULT

  • 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.

    PMID: 41738148RESULT

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

yuan xue yan, MD, MD

CONTACT

+86 8326255018826401594@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pH.D

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

March 13, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

February 20, 2030

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations

CN(15)KR(1)TW(1)