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NCT Number: NCT06990477

Effect of EIT-guided PEEP in ARDS Patients

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.

Recruiting

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EIT-guided PEEP

Device

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 outcomes

  1. 28-day mortality

    Time frame: mortality in Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

yuan xue yan, MD, MD

CONTACT

[email protected]

+86 83262550

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 25, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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