Pilot Study of a New Device to Titrate Oxygen Flow in Hypoxic Patients on Long-Term Oxygen Therapy

BACKGROUND: The O₂ Flow Regulator (Dima, Bologna, Italy) is a new automated oxygen regulator that titrates the oxygen flow based on a pulse-oximetry signal to maintain a target S_pO2. We tested the device's safety and efficacy.

METHODS: We enrolled 18 subjects with chronic lung disease, exercise-induced desaturation, and on long-term oxygen therapy, in a randomized crossover study with 2 constant-work-load 15-min cycling exercise tests, starting with the patient's previously prescribed usual oxygen flow. In one test the oxygen flow was titrated manually by the respiratory therapist, and in the other test the oxygen flow was titrated by the O₂ Flow Regulator, to maintain an S_pO2 of 94%. We measured S_pO2 throughout each test, the time spent by the respiratory therapist to set the device or to manually regulate the oxygen flow, and the total number of respiratory-therapist titration interventions during the trial.

RESULTS: There were no differences in symptoms or heart rate between the exercise tests. Compared to the respiratory-therapist-controlled tests, during the O₂ Flow Regulator tests S_pO2 was significantly higher (95 ± 2% vs 93 ± 3%, P = .04), significantly less time was spent below the target S_pO2 (171 ± 187 s vs 340 ± 220 s, P < .001), and the O₂ Flow Regulator tests required significantly less respiratory therapist time (5.6 ± 3.7 min vs 2.0 ± 0.1 min, P = .005).

CONCLUSIONS: The O₂ Flow Regulator may be a safe and effective alternative to manual oxygen titration during exercise in hypoxic patients. It provided stable S_pO2 and avoided desaturations in our subjects.