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 patients with higher recruitability.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Feb 2029

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
8 months until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2029

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 18, 2025

Last Update Submit

January 29, 2026

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    mortality in Day 28

Study Arms (2)

EIT-guided 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 88% and 95%, and PaO2 between 55mmHg and 80mmHg.

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 and then reduced in steps of 2cmH2O from 20 to 6 every 2min.

EIT-guided group

Eligibility Criteria

Age19 Years - 85 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)
  • RI ratio \> 0.5 measured for clinical reasons in the previous 24 hours
  • 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
  • Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Critical Care Medicine, Zhongshan Hospital of Fudan University

Shanghai, China Mainland, 200000, China

NOT YET RECRUITING

Department of Critical Care Medicine, Renji Hospital

Shanghai, China Mainland, 20000, China

NOT YET RECRUITING

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

yuan xue yan, MD, MD

CONTACT

+861590159965918826401594@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

January 28, 2026

Primary Completion (Estimated)

January 19, 2029

Study Completion (Estimated)

February 20, 2029

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

CN(3)