Real-time algorithm-driven ventilation feedback to improve lung-protective ventilation in patients with ARDS (REALVENT-study): study protocol for a multicentre randomised controlled trial.

Summary

This is the protocol for a multicentre, open-label RCT (n=208) testing a cloud-based, real-time respiratory mechanics feedback platform aiming to increase adherence to lung-protective ventilation targets in ARDS over the first 72 hours. Primary outcome is the lung-protective ventilation achievement rate; secondary outcomes include ventilator-free days, ICU length of stay, complications, biomarkers and safety endpoints.

Key Findings

• Protocol for a multicentre RCT (n=208) comparing standard monitoring vs cloud-based real-time feedback in ARDS.
• Primary outcome: lung-protective ventilation achievement rate over first 72 hours defined by VT, driving pressure, plateau pressure, and mechanical power thresholds.
• Secondary outcomes include ventilator-free days at day 28, ICU LOS, complications, inflammatory biomarkers, clinician satisfaction, and predefined safety endpoints.

Clinical Implications

Potential to increase adherence to low VT/driving pressure/limited mechanical power strategies in the early ARDS period; could be adopted as a decision-support tool in ICUs pending positive trial results.

Limitations

• Open-label design may introduce performance bias despite objective endpoints.
• Conducted in mainland China ICUs; generalizability to other healthcare systems and device ecosystems may require validation.

Future Directions

If efficacy is demonstrated, next steps include implementation studies across diverse ICU settings, cost-effectiveness analysis, and integration with closed-loop ventilation systems.