RecruitingNot ApplicableNCT07307066

Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)

Sponsor

Peking Union Medical College Hospital

Enrollment

208 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Respiratory Failure Critical Illness ARDS (Acute Respiratory Distress Syndrome)VILI (Ventilator-induced Lung Injury)

Summary

The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically and Standard ICU care for people with ards (acute respiratory distress syndrome), critical illness, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEREal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically

Patients in the intervention arm will receive real-time ventilator waveform monitoring through the respiratory dynamics monitoring and feedback RemoteVentilate ViewTM system. The system continuously collects high-frequency waveform data (flow, pressure, volume) directly from the ventilator interface and analyses the following metrics: Tidal volume (VT) indexed to predicted body weight, Driving pressure (ΔP), Plateau pressure (Pplat), and Mechanical power (MP). Patient-ventilator asynchrony (PVA) events will be also collected in the system, including double triggering, ineffective efforts, reverse triggering, and flow starvation, etc..

OTHERStandard ICU care

The control group will receive standard ICU care, including routine monitoring of ventilator parameters such as tidal volume, plateau pressure, and oxygenation status. No structured feedback or external ventilation reports will be provided. This reflects the prevailing standard of care in Chinese ICUs and is thus an appropriate comparator for assessing the added value of a real-time respiratory feedback platform.