Development and Evaluation of an Automated Manual Resuscitator-Based Emergency Ventilator-Alternative

Mass casualty incidents such as those that are being experienced during the novel coronavirus disease (COVID-19) pandemic can overwhelm local healthcare systems, where the number of casualties exceeds local resources and capabilities in a short period of time. The influx of patients with lung function deterioration as a result of COVID-19 has strained traditional ventilator supplies. To bridge the gap during ventilator shortages and to help clinicians triage patients, manual resuscitator devices can be used to deliver respirations to a patient requiring breathing support. Bag-valve mask (BVM) devices are ubiquitous in ambulances and healthcare environments, however require a medical professional to be present and constantly applying compression to provide the patient with respirations. We developed an automated manual resuscitator-based emergency ventilator-alternative (AMREV) that provides automated compressions of a BVM in a repetitive manner and is broadly compatible with commercially-available BVM devices approximately 5 inches (128 mm) in diameter. The AMREV device relieves the medical professional from providing manual breathing support and allows for hands-free operation of the BVM. The AMREV supports the following treatment parameters: 1) adjustable tidal volume (V(T)), 2) positive end-expiratory pressure (PEEP) (intrinsic and/or external), 3) 1:1 inspiratory: expiratory ratio, and 4) a controllable respiratory rate between 10-30 breaths per minute. The relationship between the inherent resistance and compliance of the lung and the delivered breaths was assessed for the AMREV device. Adjustable V(T) of 110-700 ml was achieved within the range of simulated lung states. A linear increase in mean airway pressure (P(aw)), from 10-40 cmH(2)O was observed, as the resistance and compliance on the lung model moved from normal to severe simulated disease states. The AMREV functioned continuously for seven days with less than 3.2% variation in delivered V(T) and P(aw). Additionally, the AMREV device was compatible with seven commercially-available BVM setups and delivered consistent V(T) and P(aw) within 10% between models. This automated BVM-based emergency-use resuscitator can provide consistent positive pressure, volume-controlled ventilation over an extended duration when a traditional ventilator is not available. True ventilator shortages may lead to manual resuscitators devices such as the AMREV being the only option for some healthcare systems during the COVID-19 pandemic.