Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Critica… (NCT07307066) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Critically Ill Patients
208 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Chronic ventilator dependence, defined as ≥ 21 consecutive days of mechanical ventilation prior to the current admission
* 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
What they're measuring
1
The daily lung-protective ventilation achievement rate
Timeframe: Over the first 72 hours following randomisation