Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)
Recruiting now · Not applicable
Conditions studied: ARDS (Acute Respiratory Distress Syndrome), VILI (Ventilator-induced Lung Injury), Respiratory Failure, Critical Illness
In brief
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.
Key facts
- Study ID
- NCT07307066
- Run by
- Peking Union Medical College Hospital
- People needed
- 208
- Starts
- 2025-12-30
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75 years
- Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening
- Initiation of invasive mechanical ventilation within the past 24 hours
- PaO₂/FiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂/FiO₂ ≤ 235 with SpO₂ ≤ 97%
- Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment
You may not qualify if…
- Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening
- Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours
- Pregnancy
- Known neuromuscular disease affecting spontaneous respiratory effort
- Prisoners or individuals unable to provide informed consent or surrogate consent
- Simultaneous enrollment in another interventional ICU study
- Lack of digital infrastructure for real-time ventilator waveform acquisition
Where it is running
- Qujing Central Hospital of Yunnan Province — Qujing, Yunnan, China (enrolling)
Full record on ClinicalTrials.gov
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