EIT-guided PEEP for ARDS patients with higher lung recruitability

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

This trial tests whether using bedside electrical impedance tomography (EIT) to set PEEP helps adults with moderate-to-severe ARDS who show higher lung recruitability.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 19 Years to 85 Years
• Sex: All
• Sponsor: Southeast University, China (Academic / other)
• Locations: 3 sites (Shanghai, China Mainland and 2 other locations)
• Trial ID: NCT06990477 on ClinicalTrials.gov

What this trial studies

This interventional study compares PEEP set using bedside electrical impedance tomography (EIT) with standard FiO2-PEEP table settings in mechanically ventilated adults with moderate-to-severe ARDS and higher recruitability. Patients eligible are adults within 72 hours of ARDS diagnosis, with a PaO2/FiO2 ≤200 and an RI ratio >0.5 measured within 24 hours. The EIT-guided approach individualizes PEEP based on regional ventilation distribution to try to improve lung recruitment while limiting overdistention. Clinical outcomes, including markers of oxygenation and ventilator-related complications, are compared between groups at participating ICUs.

Who should consider this trial

Good fit: Adults (≥18 years) with moderate-to-severe ARDS (PaO2/FiO2 ≤200 on PEEP ≥5 cmH2O), an RI ratio >0.5 measured within the prior 24 hours, ARDS diagnosis under 72 hours old, and expected to require mechanical ventilation beyond 48 hours are the ideal candidates.

Not a fit: Patients with low recruitability, contraindications to EIT (for example pacemakers or implanted defibrillators), those on ECMO, with short expected ventilation duration, or with severe comorbid organ failure are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, EIT-guided PEEP could improve oxygenation and reduce ventilator-induced lung injury for ARDS patients whose lungs are more recruitable.

How similar studies have performed: Small studies and pilot data, including prior work from these investigators, suggest EIT-guided PEEP can benefit selected patients, but larger definitive trials are still limited and results across studies have been mixed.

Eligibility criteria

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. RI ratio \> 0.5 measured for clinical reasons in the previous 24 hours
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

Where this trial is running

Shanghai, China Mainland and 2 other locations

• Department of Critical Care Medicine, Zhongshan Hospital of Fudan University — Shanghai, China Mainland, China (Not_yet_recruiting)
• Department of Critical Care Medicine, Renji Hospital — Shanghai, China Mainland, China (Not_yet_recruiting)
• Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: yuan xue yan, MD, MD

Conditions ARDS