Michelle Dundek1,2, Ellie Ng1, Brazil Abigail1, M DiBlasi Robert3,4, A Poli Jonathan3, F Burke Thomas1,2,5,6. 1. Vayu Global Health Foundation, Boston, MA. 2. Global Health Innovation Lab, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA. 3. Department of Respiratory Care Therapy, Seattle Children's Hospital and Regional Medical Center, Seattle, WA. 4. Center for Integrative Brain Research, Seattle Children's Research Institute, Seattle, WA. 5. Harvard Medical School, Boston, MA. 6. Harvard T.H. Chan School of Public Health, Boston, MA.
Abstract
BACKGROUND: Despite its established safety, efficacy, and relative simplicity, CPAP treatment is not widely available for newborns and infants in low- and middle-income settings (LMICS). A novel bubble CPAP (B-CPAP) system was designed to address the gaps in quality and accessibility of existing CPAP systems by providing blended, humidified and pressurized breathing gases without the need for electricity, compressed air, or manual power. This is the first study that tested the performance of the system with a simulated patient model. METHODS: In a spontaneously breathing 3D printed nasal airway model of a pre-term neonate, CPAP performance was assessed based on delivered pressure, oxygen level, and humidity at different settings. RESULTS: Preliminary device performance characteristics were within 5% between three separate devices. Performance testing showed accurate control of CPAP and oxygen concentration at all settings with the B-CPAP system. Lung model pressure and oxygen concentration were shown to stay within ± 0.5 cmH2O and ± 4% of full scale (FS) of the device settings, respectively, with relative humidity levels of >80%. CONCLUSIONS: Performance testing of the B-CPAP system demonstrates accurate control of CPAP and oxygen concentration with humidity levels suitable for premature newborns on noninvasive support.
BACKGROUND: Despite its established safety, efficacy, and relative simplicity, CPAP treatment is not widely available for newborns and infants in low- and middle-income settings (LMICS). A novel bubble CPAP (B-CPAP) system was designed to address the gaps in quality and accessibility of existing CPAP systems by providing blended, humidified and pressurized breathing gases without the need for electricity, compressed air, or manual power. This is the first study that tested the performance of the system with a simulated patient model. METHODS: In a spontaneously breathing 3D printed nasal airway model of a pre-term neonate, CPAP performance was assessed based on delivered pressure, oxygen level, and humidity at different settings. RESULTS: Preliminary device performance characteristics were within 5% between three separate devices. Performance testing showed accurate control of CPAP and oxygen concentration at all settings with the B-CPAP system. Lung model pressure and oxygen concentration were shown to stay within ± 0.5 cmH2O and ± 4% of full scale (FS) of the device settings, respectively, with relative humidity levels of >80%. CONCLUSIONS: Performance testing of the B-CPAP system demonstrates accurate control of CPAP and oxygen concentration with humidity levels suitable for premature newborns on noninvasive support.