FIx controller: an instrument to automatically adjust inspired oxygen fraction using feedback control from a pulse oximeter.

Objective: To develop an instrument to help prevent pulmonary O2 toxicity, a syndrome that manifests itself in adult intensive care patients.

Methods: We designed, built, and tested a device that controls FIO2 exposure using oxygen saturation measured with a pulse oximeter (SpO2) in a negative feedback control system. A target SpO2 is designated by the clinician and the system adjusts the FIO2 from a mechanical ventilator so as to minimize the difference between the measured SpO2 and the target. Important elements of the system include a conservative artifact rejection algorithm, a gainscheduled sampled-data proportional-integral-derivative (PID) controller, and a safety system to prevent inspired mixtures with undesirably low FIO2 due to device failure.

Results: The control system was tuned in a series of animal experiments. Acceptable clinical response of the system was obtained using a gain-scheduled controller algorithm whereby the gain of the proportional term of a PID controller was adjusted based on the error signal and measured minute ventilation. Also, the artifact rejection algorithm and safety systems were successfully tested using simulation.

Conclusions: Testing the effectiveness of this instrument will require comparison with manual control of FIO2 in an appropriately designed trial.