Oxygen efficient respiratory Aid (OxEraTM) device: A safety study.

Abstract

Severe Coronavirus Disease 2019 (COVID-19) can develop pneumonia with severe complications. The Oxygen Efficient Respiratory Aid (OxEraTM) device has been granted SAPHRA approval for emergency COVID-19 pandemic use. The device has the potential to be used widely in the healthcare sector due to its efficient oxygen supply and adjustable wall positive expiratory pressure (PEP). We assessed whether the OxEraTM device was safe to use in a healthy adult volunteer population. Our primary objective was to ensure there was no asphyxiation, as assessed by changes observed from baseline End Tidal Carbon Dioxide (ETCO2) exceeding 6.3mmHg and above the 45mmHg threshold. We also monitored changes in vital organ signs and assessed the pain and comfort of the participant at various intervals with changes in PEPs. This was an experimental safety study of the OxEraTM Device on 30 healthy participants at the ICU training centre of Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa. Each participant had basic vital-signs, ETCO2, and Oxygen saturation percentages (SpO2%) taken at baseline until the end of 2h. In the first 20min, the PEP was increased by 5cmH20 until 20min, then continued for the rest of the time on a PEP of 5cmH20. At each interval, vital signs, subjective comfort, pain, and visual scores were measured. Thirty healthy participants were enrolled. There was no significant difference in ETCO2 from baseline until 2h. No participant experienced an increase in measured ETCO2 greater than 45mmHg and no increase in ETCO2 from baseline was greater than 6.3mmHg. The median increase in ETCO2 over the study period was 2mmHg. There were no significant changes in respiratory rate and blood pressure. The heart rate decreased significantly (73-68bpm). The VAS and comfort score had a significant increase over the 2h from baseline of 0-2 at maximum; however, the PAS scores showed no significant increase. Overall the OxEraTM device achieved the safety endpoints set out. There was no sign of asphyxiation and there were appropriate physiological responses to changes in PEP once applied. The comfort of the mask did worsen over the 2h; however, the scores were minimally worse on PEP application but improved once-off PEP. No adverse event was recorded at all.