Continuous Flow Ventilation With the Ventijet System in Acute Respiratory Distress Syndrome: a First-in-Human Feasibility and Non-Inferiority Trial

This prospective, non-randomized, single-arm, proof-of-concept clinical trial evaluates the physiological performance and safety of the Ventijet System, a hybrid ventilation system based on continuous high-velocity gas flow. The system was conceived during the coronavirus disease 2019 (COVID-19) pandemic as a response to ventilator shortages, building upon a previously patented continuous-flow nozzle system developed by Dr. Lucas Picazo in the 1990s. The concept combines the physiological benefits of continuous flow ventilation (CFV) with the potential ease of design, monitoring, and scalability. Patients with moderate acute respiratory distress syndrome (ARDS) - defined by a ratio of arterial partial pressure of oxygen to inspired oxygen fraction (PaO₂/FiO₂) between 150 and 200 mmHg - were first stabilized on a conventional mechanical ventilator (Puritan Bennett 840, PB840) using lung-protective settings. They were then transitioned to the Ventijet system following a structured protocol that included real-time monitoring and esophageal pressure measurements. The primary endpoint was oxygenation, measured as the change in PaO₂ after one hour of ventilation with the Ventijet system compared to baseline values under conventional ventilation. The study was designed to demonstrate non-inferiority, with a predefined margin of ±20 mmHg in PaO₂. Secondary outcomes included carbon dioxide clearance (PaCO₂), respiratory system mechanics, safety events, and feasibility in intensive care unit (ICU) conditions.