A pilot study to evaluate the safety and efficacy of automated mechanical Respiratory aid device “RespirAID R20” in post operative care patients

Gautham Pasupuleti, Meghna Mukund, Sharon George, Srimathi Bai KM

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

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