From Rapid Manufacturing to Clinical Use: A Retrospective Observational Study of an Emergency Ventilator During the COVID-19 Pandemic.

Abstract

Objective: The COVID-19 pandemic spurred efforts to develop emergency ventilators, though few progressed beyond laboratory testing. This study evaluates CoroVent, a rapidly manufactured ventilator, during real-life deployment in critically ill COVID-19 patients amid ventilator shortages.

Methods: This retrospective observational study included patients ventilated with emergency ventilator CoroVent. This device uses a novel and unique way of generating inspiratory flow and gas mixing using fast ON/OFF valves for air and oxygen, producing pneumatic pulses that are then smoothed into continuous flow. Clinical data were collected from 3 hospitals between October 2020 and March 2021, selected from 27 contacted, of which 23 responded and 4 reported clinical use.

Results: Eight male patients (mean age 67 years, BMI 37.2 kg·m^-2) with COVID-19 or suspected infection were ventilated with CoroVent for 31.3 (10.0-58.5) hours. The mean FiO₂ was 71.4%, PEEP 10.6 cmH₂O, and Vt 8.9 mL·kg^-1 predicted body weight. CoroVent was used as an initial or replacement ventilator during device shortages. No major technical failures occurred.

Conclusions: This is the first report of real-life clinical use of a rapidly manufactured emergency ventilator during the COVID-19 pandemic. The results confirm that such devices, if well-designed, can provide effective respiratory support when conventional ventilators are unavailable.