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

Not Applicable

Not yet recruiting

• Conditions: ARDS (Acute Respiratory Distress Syndrome)

• Registration Number: NCT06990477
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age≥18 years
2. 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)
3. Patients with tidal volume of 6 mL/Kg would require a driving pressure of ≥ 13 cmH2O and the percentage of collapse monitoring by EIT >25%
4. Diagnosis of ARDS less than 72 hours

Exclusion Criteria

1. Expected to be mechanically ventilated for less than 48 hours
2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
3. Undrained pneumothorax or subcutaneous emphysema
4. Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
5. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
6. Severe neuromuscular disease
7. Hemodynamic instability
8. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
9. Severe other organs dysfunction with a low expected survival (7 days) or palliative care
10. Solid organ or hematologic tumors with the expected survival time less than 30 days
11. Participating in other clinical trials within 30 days
12. Pregnancy
13. Refusal to sign the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
28-day mortality	mortality in Day 28