REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in criticallyStandard ICU care
REal-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..
Standard 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
The daily lung-protective ventilation achievement rate — Over the first 72 hours following randomisation 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
Trial sites (1)
Facility
City
Region
Status
Qujing Central Hospital of Yunnan Province
Qujing
Yunnan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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