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

Area of Science:

• Medical Devices
• Respiratory Care
• Clinical Safety Studies

Background:

• Severe COVID-19 can lead to pneumonia and complications.
• The OxEra™ device offers efficient oxygen supply and adjustable positive expiratory pressure (PEP).
• SAPHRA approval was granted for emergency COVID-19 pandemic use of the OxEra™ device.

Purpose of the Study:

• To evaluate the safety of the OxEra™ device in healthy adult volunteers.
• Primary safety endpoint: absence of asphyxiation, defined by End Tidal Carbon Dioxide (ETCO₂) levels.
• Secondary endpoints included monitoring vital signs and participant comfort with varying PEP levels.

Main Methods:

• Experimental safety study involving 30 healthy participants.
• Measurements included vital signs, ETCO₂, and SpO₂ at baseline and over 2 hours.
• Positive expiratory pressure (PEP) was incrementally applied and maintained, with comfort and pain assessments.

Main Results:

• No significant changes in ETCO₂ from baseline; no participant exceeded safety thresholds.
• No significant alterations in respiratory rate or blood pressure were observed.
• Heart rate decreased slightly, while pain and comfort scores showed minimal, non-adverse changes.

Conclusions:

• The OxEra™ device met its predefined safety endpoints in healthy adults.
• No evidence of asphyxiation was detected, and physiological responses to PEP were appropriate.
• No adverse events were recorded, indicating the device's safety for this population.