FDA Emergency Use Authorization-Approved Novel Coronavirus Disease 2019, Pressure-Regulated, Mechanical Ventilator Splitter That Enables Differential Compliance Multiplexing

Abstract

Infection with the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may cause viral pneumonia and acute respiratory distress syndrome (ARDS). Treatment of ARDS often requires mechanical ventilation and may take weeks for resolution. In areas with a large outbreaks, there may be shortages of ventilators available. While rudimentary methods for ventilator splitting have been described, given the range of independent ventilatory settings required for each patient, this solution is suboptimal. Here, we describe a device that can split a ventilator among up to four patients while allowing for individualized settings. The device has been validated in vitro and in vivo .

Figure 1.

The ventilator sharing and monitoring system (VSMS). A: System airflow circuit diagram of the VSMS. Each ventilation line is equipped with adjustable flow and check valves allowing for independent regulation of a wide variety of ventilation settings and isolated air circuits, reducing the risk of cross contamination. B: Prototype VSMS device with callouts to relevant external components. C: Device monitoring display with graphical user interface.

Figure 2.

In vivo testing of VSMS using two sheep with different weights. A: Two sheep tested using the VSMS system. B: Ventilation volume changes over time. C: Pressure changes over time. D: Anteroposterior and lateral chest x-rays of both sheep pre- and post-VSMS testings. PIP, peak inspiratory pressure; PEEP, positive end-expiratory pressure; VSMS, ventilator sharing and monitoring system.