Evaluation of a Bubble CPAP System for Low Resource Settings

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. A novel bubble CPAP system was designed to address the gaps in quality and accessibility of existing CPAP systems by providing blended, humidified, and pressurized gases without the need for electricity, compressed air, or manual power. This was the first study that tested the performance of the system with a simulated patient model. METHODS: In a spontaneously breathing 3dimensional printed nasal airway model of a preterm neonate, CPAP performance was assessed based on delivered pressure, oxygen level, and humidity at different settings. RESULTS: Preliminary device performance characteristics were within 5% among 3 separate devices. Performance testing showed accurate control of CPAP and oxygen concentration at all settings with the bubble CPAP system. Lung model pressure and oxygen concentration were shown to stay within 60.5 cm H 2 O and 64% of full scale of the device settings, respectively, with relative humidity > 80%. CONCLUSIONS: Performance testing of the bubble CPAP system demonstrated accurate control of CPAP and oxygen concentration with humidity levels suitable for premature newborns on noninvasive support.

Feasibility of a Novel Ultra-Low-Cost Bubble CPAP (bCPAP) System for Neonatal Respiratory Support at Muhimbili National Hospital, Tanzania

“…A concern with the Vayu bCPAP Systems was occasional disconnection of the oxygen tubing from the blender at FiO2s greater than .60. (17) Upon further investigation it was found that oxygen tubing (Figure 1A) that had been reprocessed many times (distinguishable by exterior hardening/yellowing) became vulnerable to disconnection at higher FiO2s. Hose clamps were introduced as an interim measure to secure older oxygen tubing, and subsequently the material of the oxygen tubing was modified to increase the hardness (from ASTM D 2240 Shore A 70 hardness to 80 hardness).…”

“…(16) The novel Vayu bCPAP System was developed to overcome current barriers to scale, and to make high quality CPAP available for global access. (17) Vayu bCPAP Systems have been used for three years to treat neonates with RDS, pneumonia, COVID-19, and other causes of severe respiratory distress in 13 countries. The Vayu bCPAP System revolves around an innovative air/oxygen blender that supplies the circuit with oxygen enriched air.…”

“…1A). (17) The Vayu bCPAP System does not require electricity or compressed air and was granted regulatory approval in a number of countries, including US FDA Emergency Use Authorization, Kenya, and Tanzania.…”

Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support

“…Other designs of bCPAP and Venturi-type blenders are currently in various stages of development. [26][27][28] Our circuit design is distinct in that it uses a RAM cannula for patient interface rather than nasal prongs resembling Hudson RCI ® products. Our team selected a RAM cannula because this type of interface is simple to secure on the patient's face and is likely to be more feasible in LMIC environments where nursing ratios for neonatal in-patient care are relatively high.…”

Evaluation of an innovative low flow oxygen blender system for global access

“…In 2020, Mollazadeh-Moghaddam et al described a Venturi device that could deliver low flows of blended air/oxygen to thin tubing like nasal cannula ( 14 ). Similar Venturi devices have been used in CPAP systems before, but not for low flow infant nasal cannula oxygen therapy ( 15 , 16 ). The design of this Venturi device was improved and integrated into a circuit with a low resistance nasal cannula to create a complete system for delivery of blended air/ oxygen to infants and children up to age five (Vayu Global Health Innovations, Boston, MA, USA).…”