Autonomous Oxygen Titration

The O2matic PRO100 is a trend-based, closed-loop autonomous oxygen titration system approved in 32 countries, including the EU, Australia, and New Zealand, but not yet FDA-approved in the USA. In the intervention group, the PRO100 is programmed to an internal SpO₂ range of 92–94%, targeting 93%. Most prior evidence for autonomous titration concerns mechanically ventilated patients, but most oxygen-receiving inpatients breathe spontaneously. Preliminary clinical evidence showed the PRO100 reduced both hypoxemia and hyperoxemia in patients with COVID-19 pneumonia and in patients with COPD. Closed-loop autonomous oxygen titration systems continuously adjust oxygen flow in real time to keep SpO₂ within a clinician-specified range. Escalation beyond 15 L/min or evidence of advancing respiratory failure triggers removal from the autonomous system. In the usual care group, the PRO100 is attached in observation mode only, with autonomous titration disabled. The PRO100 is being evaluated in this trial under an FDA Investigational Device Exemption.