Simple CPAP (SIMPAP) for Neonatal Transport—Device Development and Proof of Concept Study

Abstract

Objective:

To develop a low-cost, easy to use CPAP device with a simple patient interface—SIMPAP.

Design:

This was an in vitro experimental study. SIMPAP was designed and developed over three iterations to be able to use in clinical studies. SIMPAP consists of intersecting cylinders with each opening performing a designated function. One of the openings serves as an extremely short expiratory limb that is fitted with a calibrated occlusion. This results in a nonrebreathing system that generates predetermined pressure against which the baby has to exhale.

Main Outcome Measure:

To analyze the pressures generated by the initial prototypes of the SIMPAP device.

Results:

Four SIMPAP bodies and four pressure relief valves were tested with different combinations as four exercises. Mean (–2Sd to +2SD) pressure generated at a flow rate of 1 liter was 3.4 (2.2-4.7) cm of H₂O and at 2 liters per min flow was 5.7 (4.8-6.6) cm of H₂O. The 95% limit of agreement between exercises 1 and 2 was –0.4 to +1 cm of H₂O, and between exercises 1 and 3 and 1 and 4 was –1 to +1 cm of H₂O across the pressure range.

Conclusion:

SIMPAP can deliver therapeutic CPAP at low gas flow rates. Further clinical studies are warranted to establish the efficacy and safety of this new device on neonates.