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
Parallel
REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically
DevicePatients 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..
Standard ICU care
Other interventionThe 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.
The daily lung-protective ventilation achievement rate
The primary outcome is the daily lung-protective ventilation achievement rate over the first 72 hours following randomisation. Lung-protective ventilation is defined as simultaneous fulfilment of all of the following four criteria: Tidal volume (VT) \< 8 mL/kg predicted body weight (PBW); Driving pressure (ΔP) \< 15 cmH₂O; Plateau pressure (Pplat) \< 30 cmH₂O; Mechanical power (MP) \< 17 J/min. The daily achievement rate is calculated as the number of hours within each 24-hour period where all four targets are met, divided by 24, and expressed as a percentage. The mean of the three daily rates over the 72-hour period will be used as the primary outcome. This outcome reflects both physiological safety and clinician behaviour, and was selected based on its strong mechanistic link with ventilator-induced lung injury and previous observational data on variability in adherence
Ventilator-free days at day 28 (VFD-28)
defined as the number of days alive and free from invasive mechanical ventilation between randomisation and day 28, with patients who die before day 28 considered as having 0 VFDs;
ICU length of stay
total number of days from ICU admission to ICU discharge;
Serum concentration of interleukin-1 beta (IL-1β)
Serum IL-1β concentration measured using standardized immunoassays.
Serum concentration of interleukin-6 (IL-6)
Serum IL-6 concentration measured using standardized immunoassays.
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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
