A closed-loop controller for mechanical ventilation of patients with ARDS.

Mechanical ventilators are routinely used to care for patients who cannot adequately breath on their own. Management of mechanical ventilation often involves a careful watch of the patient's arterial blood-oxygen tension and requires frequent adjustment of ventilation parameters to optimize the therapy. This situation lends itself as a candidate for closed-loop control. This report describes a closed-loop control system based on well-established protocols to systematically maintain appropriate levels of positive end-expiratory pressure (PEEP) and inspired oxygen (FiO2) in patients with Adult Respiratory Distress Syndrome (ARDS). The closed-loop control system consists of an in-dwelling arterial oxygenation (PaO2) sensor (Pfizer Continucath), coupled to a Macintosh computer that continuously controls FiO2 and PEEP settings on a Hamilton Amadeus ventilator. The implemented protocols provide continuous closed-loop control of oxygenation and a balance between patient need and minimal therapy. The controller is based on a traditional proportional-integral-derivative (PID) approach. The idea is to control, or maintain, the patient's PaO2 level at a target value determined, or set, by the patient's physician. The controller also features non-linear and adaptive characteristics that allow the system to respond more aggressively to "threatening" levels of PaO2. Another benefit of the control system is the ability to display, monitor, record and store all system parameters, settings, and control variables for future analysis and study. The system was extensively tested in the laboratory and in animal trials prior to use on human subjects. The results of a small clinical trial indicated that the system maintained control of the patient's therapy nearly 84% of the time. During the remainder of this time, the controller was interrupted primarily for suctioning, PaO2 sensor calibration or replacement. The response of the closed-loop controller was found to be appropriate, reliable and safe in patients with ARDS.