Background

98% of under-5 years old children annual deaths occur in low and middle-income countries (LMICs) and are mostly associated with hypoxaemia. Effective implementation of respiratory support could significantly reduce these deaths, but it is limited by the lack of affordable and reliable oxygen supplies.

Aims

We developed a respiratory support CPAP device specifically designed for LMICs, integrating a turbine-operated ventilator and an oxygen concentrator. This study aims to: 1)validate the prototype in vitro; 2)test its usability on the field.

Methods

A breath simulator mimicking infants breathing pattern of 1.5-4 kg newborns was used for in vitro validation. CPAP was changed from 3 to 15 cmH₂O in steps of 3 cmH₂O, and the fraction of inspired oxygen (FiO₂) from 25% to 70% in 5% steps. CPAP and FiO₂ were measured at the airway opening, and compared to the set target.

Usability was tested by 15 nurses (Aber, Uganda) who were asked to perform six tasks on a mannequin after receiving a 20-min training. For each task, we recorded number and type of misuses. Participants also filled the Post-Study System Usability Questionnaire (PSSUQ), including 16 items scored from 0 (best) to 7 (worst).

Results

The difference between set and measured values was always <1.5% for CPAP and <6 % for FiO₂. Participants made a total of 5 mistakes, 3 of which concerning the start-up of the device. The mean PSSUQ score was 1.64±0.49, showing high appreciation for the device.

Conclusion

The prototype proved effective in delivering oxygen-enriched CPAP in absence of oxygen sources, and was found to be easy-to-use by healthcare personnel in a resource-limited setting.