The OxyMask(™) development and performance in healthy volunteers

Area of Science:

• Respiratory therapy
• Biomedical engineering
• Medical device design

Background:

• The original OxyMask, an open-style oxygen mask developed in 2005, was modified to achieve a broader range of inspired oxygen fractions (FiO2).
• Computational fluid dynamics (CFD) simulations guided the redesign of the mask shell and oxygen diffuser placement.

Purpose of the Study:

• To evaluate the efficacy of the modified OxyMask in delivering a wide range of FiO2.
• To assess the performance of the second-generation OxyMask across various oxygen flow rates.

Main Methods:

• The modified OxyMask was tested on 10 healthy subjects.
• Escalating oxygen flow rates (1.5 to 30 LPM) were administered for 90 seconds each.
• Fraction of inspired oxygen (FiO2) was measured at the lips using 5 consecutive readings per flow rate.

Main Results:

• Mean FiO2 ranged from 25.4% at 1.5 LPM to 84.3% at 30 LPM.
• Significant increases in FiO2 were observed with escalating oxygen flow rates up to 15 LPM.
• FiO2 levels above 15 LPM showed minimal significant increase, with a maximum recorded FiO2 of 90% in some subjects.

Conclusions:

• The modified OxyMask successfully provides a wide range of FiO2 (25%-90%) while retaining its open-style design.
• The second-generation OxyMask offers a versatile solution for oxygen therapy.
• The study confirms the effectiveness of CFD in optimizing medical device design for improved performance.