A pilot study to evaluate the safety and efficacy of automated mechanical respiratory aid device

Abstract

Background: High burden of morbidity and mortality due to respiratory illnesses was witnessed during the COVID-19 pandemic. We developed a portable automated mechanical respiratory assist device (RespirAID R20) that delivers Intermittent Positive Pressure Ventilation by mechanically compressing a Bag Valve Mask. The objective of the study is to evaluate the safety and efficacy of the RespirAID R20, a mechanical ventilation device in post-operative care patients. Method: This pilot study enrolled five subjects at Yenepoya Medical College Hospital, India. Post-operative subjects were transferred from the Mindray Synovent E3 (standard ventilator) to the RespirAID R20 for 3 hours. Ventilator and physiologic parameters were recorded and compared. Result: All patients maintained normal blood pressure, heart rate, and heart rhythm. The delivered mean tidal volume (VT) and peak inspiratory pressure (PIP) was 419.64 +/- 11 ml and 20 +/- 2 cmH2O, which remained within the initial set range of 428 +/- 12 ml and 24 +/- 2 cmH2O throughout the study duration. Arterial blood gas (ABG) parameters during RespirAID R20, except PaO2, were within the normal range. PaO2 levels were greater than 300 mm Hg during the first four hours (323 +/- 163 mmHg and 344 +/- 97 mmHg). Conclusion: The findings of this study suggests that RespirAID R20 may be an alternative device in providing respiratory assistance to sedated and intubated adult patients in the postoperative period. Additional studies are required to evaluate other possible applications of the RespirAID R20. Keywords: RespirAID R20, ABG parameters, mechanical ventilation, respiratory assist