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Recruiting NCT06990477

Effect of EIT-guided PEEP in ARDS Patients

No phase Interventional ARDS (Acute Respiratory Distress Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EIT-guided PEEP.
Who it may be relevant to
Registry conditions: ARDS (Acute Respiratory Distress Syndrome). Basic parameters: 19 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China, South Korea, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device EIT-guided PEEP
    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.

Primary outcome measures

  • 28-day mortality [Time frame: mortality in Day 28]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 15 centers
  • Second Hospital of Anhui Medical University — Hefei
  • Department of Critical Care Medicine, Zhongshan Hospital of Fudan University — Shanghai
  • Department of Critical Care Medicine, Renji Hospital — Shanghai
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou
  • The Affiliated Hospital of Hangzhou Normal University — Hangzhou
  • Zhongda Hospital, School of Medicine, Southeast University — Nanjing
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou
  • … and 7 more centers
South Korea · 1 center
  • Asan Medical Center — Seoul
Taiwan · 1 center
  • Taichung Veterans General Hospital — Taichung

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. PMID 39787604
  • 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 Res PMID 41738148

Identifiers

NCT: NCT06990477 · EITVent2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗