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Clinical Assessment of Feasibility and Safety of an Adapted Diving Mask as an Autonomous Respiratory Support in Healthy Volunteer

Beatriz Arias-Arcos, Carlos Collado-Escudero, Ariela Candelario-Cáceres, Maria J Buendia-García, Alfredo Abad-Gurumeta, Jose M Mendiguren-Santiag, Ricardo Larrainzar-Garijo

Background: The scenario of global health crisis due to SARS-CoV-2 pandemic combined with the shortage of resources in many countries has justified numerous studies to design easily replicable and economic respiratory support devices. We have developed an Adapted Diving Mask (ADM) starting from Decathlon Easy breath™ diving mask which were donated to be used as an autonomous and safe respiratory support. The aim of the present study was to prove a minimum Positive End Expiratory Pressure (PEEP) with the ADM as an autonomous respiratory support without any adverse events in healthy volunteer.

Methods: The clinical assessment was done in 22 healthy volunteers recruited among Banco Santander employees with our ADM prototype. The 3 hour monitoring was carried out in the medical instalations of Banco Santander, previous informed consent, and tutored by a physician and a nurse during all the assesment. Expiratoryinspiratory flow and pressure were registered with a pneumotachograph apart from arterial blood analysis before and after the intervention as well as the transcutaneous capnography during the whole monitoring using the ADM prototype. Any deleterious effect during the monitoring was registered in the sing-in patient sheet.

Results: There were no statistically significant differences in the baseline analysis results and after therapy, except in pO₂. Mean PEEP measured was 8.2 ± 4.2 cm H₂O with a peak measured pressure of 20 cm H₂O. No deleterious effect was observed during the monitoring.

Conclusion: The ADM has shown good tolerance and a therapeutic maintaining PEEP with no evidence of any deleterious effect or hypercapnia with its continuous use.