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.
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%
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
Peking Union Medical College Hospital
Lead sponsor
Beijing Hepingli Hospital
Collaborator
Beijing No.6 Hospital
Collaborator
Jinzhou Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Binzhou Second People's Hospital
Collaborator
Chongqing General Hospital
Collaborator
Qujing Central Hospital of Yunnan Province
Collaborator
Shandong Provincial Hospital
Collaborator
Capital Medical University Affiliated Beijing Anzhen Hospital, Nanchong Center
Collaborator