NCT07307066 Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)
| NCT ID | NCT07307066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | ARDS (Acute Respiratory Distress Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2025-12-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07307066 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ARDS (Acute Respiratory Distress Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07307066 currently recruiting?
Yes, NCT07307066 is actively recruiting participants. Contact the research team at slx77@163.com for enrollment information.
Where is the NCT07307066 trial being conducted?
This trial is being conducted at Qujing, China.
Who is sponsoring the NCT07307066 clinical trial?
NCT07307066 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 208 participants.