Actively Recruiting

Phase Not Applicable
Age: 19Years - 90Years
All Genders
ID06990477

Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Multicenter Randomized Controlled Trial

Led by Southeast University, China · Updated on 2026-05-22

2400

Participants Needed

3

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of electrical impedance tomography (EIT) to guide positive end-expiratory pressure (PEEP) settings in patients with moderate to severe acute respiratory distress syndrome (ARDS). This condition has a high risk of death, and mechanical ventilation is the main treatment, though it can sometimes cause lung injury. EIT allows bedside imaging to tailor PEEP settings individually, potentially improving outcomes compared to standard PEEP settings based on oxygen levels. Participants will be randomly assigned to one of two groups: one group will receive PEEP adjusted using EIT with a stepwise decrease during a trial, and the other group will have PEEP set according to a low PEEP-FiO2 table maintaining oxygen saturation between 90% and 96% and arterial oxygen levels between 60 and 90 mmHg. The EIT-guided group will have PEEP reduced in steps from 20 or 24 cmH2O down to 4 cmH2O every 30 seconds after a recruitment maneuver. During the study, participants will be monitored for clinical outcomes, primarily focusing on mortality 28 days after treatment begins. The study involves adult patients aged 19 to 90 years who have been diagnosed with moderate to severe ARDS within 72 hours and require mechanical ventilation. Safety and effects of the two PEEP-setting methods will be assessed, with follow-up through the 28-day period after enrollment in this multicenter randomized controlled trial sponsored by Southeast University, China.

CONDITIONS

Brief Title

Effect of EIT-guided PEEP in ARDS Patients

Who Can Participate

Age: 19Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Moderate-to-severe ARDS defined by Berlin definition with PaO2:FiO2 ratio ≤ 200 mmHg and PEEP ≥ 5 cmH2O
  • ARDS diagnosis made less than 72 hours before enrollment
Not Eligible

You will not qualify if you...

  • Expected mechanical ventilation duration less than 48 hours
  • Severe chronic respiratory diseases needing long-term oxygen or noninvasive ventilation
  • Undrained pneumothorax or subcutaneous emphysema
  • Contraindications to EIT use (pacemaker, implantable cardioverter defibrillator, implantable pumps)
  • Severe neuromuscular disease
  • Hemodynamic instability
  • Contraindications to hypercapnia (intracranial hypertension, acute coronary syndrome)
  • Severe organ dysfunction with low expected survival (7 days) or receiving palliative care
  • Solid organ or hematologic tumors with expected survival less than 30 days
  • Participation in other clinical trials within 30 days
  • Pregnancy
  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Duration of mechanical ventilation as clinically indicated

Participants receive PEEP titrated by EIT or according to the low FiO2-PEEP table to manage ARDS.

Continuous monitoring during mechanical ventilation

Trial Site Locations

Total: 3 locations

1

Department of Critical Care Medicine, Zhongshan Hospital of Fudan University

Shanghai, China Mainland, China, 200000

Not Yet Recruiting

2

Department of Critical Care Medicine, Renji Hospital

Shanghai, China Mainland, China, 20000

Not Yet Recruiting

3

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China, 210009

Actively Recruiting

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Research Team

Y

yuan xue yan, MD, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of Individualized Positive End-Expiratory Pressure Titrated by Electrical Impedance Tomography in Patients with Acute Respiratory Distress Syndrome.

Xueyan Yuan, Dongyu Chen, Yali Chao...

https://pubmed.ncbi.nlm.nih.gov/39787604

Electrical impedance tomography-guided positive end-expiratory pressure and mortality of patients with the acute respiratory distress syndrome: the EITVent randomized clinical trial.

Xueyan Yuan, Ming Zhong, Zhe Li...

https://pubmed.ncbi.nlm.nih.gov/41738148