The LeVe CPAP System for Oxygen-Efficient CPAP Respiratory Support: Development and Pilot Evaluation

Abstract

Background: The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed a significant demand on healthcare providers (HCPs) to provide respiratory support for patients with moderate to severe symptoms. Continuous Positive Airway Pressure (CPAP) non-invasive ventilation can help patients with moderate symptoms to avoid the need for invasive ventilation in intensive care. However, existing CPAP systems can be complex (and thus expensive) or require high levels of oxygen, limiting their use in resource-stretched environments.Technical Development + Testing: The LeVe (“Light”) CPAP system was developed using principles of frugal innovation to produce a solution of low complexity and high resource efficiency. The LeVe system exploits the air flow dynamics of electric fan blowers which are inherently suited to delivery of positive pressure at appropriate flow rates for CPAP. Laboratory evaluation demonstrated that performance of the LeVe system was equivalent to other commercially available systems used to deliver CPAP, achieving a 10 cm H2O target pressure within 2.4% RMS error and 50–70% FiO2 dependent with 10 L/min oxygen from a commercial concentrator.Pilot Evaluation: The LeVe CPAP system was tested to evaluate safety and acceptability in a group of ten healthy volunteers at Mengo Hospital in Kampala, Uganda. The study demonstrated that the system can be used safely without inducing hypoxia or hypercapnia and that its use was well-tolerated by users, with no adverse events reported.Conclusions: To provide respiratory support for the high patient numbers associated with the COVID-19 pandemic, healthcare providers require resource efficient solutions. We have shown that this can be achieved through frugal engineering of a CPAP ventilation system, in a system which is safe for use and well-tolerated in healthy volunteers. This approach may also benefit other respiratory conditions which often go unaddressed in Low and Middle Income Countries (LMICs) for want of context-appropriate technology designed for the limited oxygen resources available.

First use of a new frugal CPAP device: the LeVe CPAP System, in adult patients with COVID-19 pneumonitis at Mengo Hospital, Kampala, Uganda

“…More admissions were females than male (205 vs 128), with 64 of the 205 females either pregnant or recently post-partum. The majority of the patients were Ugandan (311) with a low number of non-nationals and refugees (22). Clinically, the majority of patients were deemed to have severe disease (197), and critical disease (72) as demonstrated in Figure 2.…”

“…It has been developed using frugal engineering techniques to tailor the technology to LMIC settings. It has been designed to provide CPAP sustainably; by creating a device that is oxygen e cient, compatible with a range of oxygen sources, cost-e cient, easy to maintain, safe, and well tolerated (22). All consumables are able to be purchased locally and affordably.…”

“…It can deliver a range of pressures through varying the fan speed. A 4-way dial allows selection of different pressure settings (5, 7.5, 10, 12.5 cmH 2 O) (22). The device generates pressurised air ow independent of the supplied oxygen.…”

“…The rst stage of clinical testing was a pilot study in healthy adults at Mengo Hospital. The results were encouraging, demonstrating the devices caused no harm in terms of oxygen saturation levels or end tidal carbon dioxide levels, as well as being well tolerated by users (22). The next stage was planned to be a crossover trial using the LeVe devices and other commercially available HFNO and CPAP devices available at Mengo Hospital (AIRVO™ and Elisa).…”

Descriptive account of the first use of the LeVe CPAP System, a new frugal CPAP System, in adult patients with COVID-19 Pneumonitis in Uganda

“…The LeVe CPAP device is a novel CPAP device designed through collaboration between Mengo Hospital and The University of Leeds, in response to the COVID-19 pandemic [ 22 ]. It has been developed using frugal engineering techniques to tailor the technology to LMIC settings.…”