Oxygen efficient respiratory Aid (OxEra^TM) device: A safety study

Severe Coronavirus Disease 2019 (COVID-19) can develop pneumonia with severe complications. The Oxygen Efficient Respiratory Aid (OxEra^TM) 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 OxEra^TM 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 6.3 mmHg and above the 45 mmHg 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 OxEra^TM 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 2 h. In the first 20 min, the PEP was increased by 5 cmH₂0 until 20 min, then continued for the rest of the time on a PEP of 5 cmH₂0. 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 2 h. No participant experienced an increase in measured ETCO₂ greater than 45 mmHg and no increase in ETCO₂ from baseline was greater than 6.3 mmHg. The median increase in ETCO₂ over the study period was 2 mmHg. There were no significant changes in respiratory rate and blood pressure. The heart rate decreased significantly (73-68 bpm). The VAS and comfort score had a significant increase over the 2 h from baseline of 0-2 at maximum; however, the PAS scores showed no significant increase.

Overall the OxEra^TM 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 2 h; however, the scores were minimally worse on PEP application but improved once-off PEP. No adverse event was recorded at all.