The CircumVent Project: a CPAP/O2 helmet solution for non-invasive ventilation using an implementation research framework

Abstract

Background Acute respiratory failure, a major cause of death in COVID-19, is managed with high-flow oxygen therapy via invasive mechanical ventilation. In resource-limited settings like Nigeria, the shortage of ventilators and oxygen supply makes this option challenging. Evidence-based non-invasive alternatives to mechanical ventilation such as the use of continuous positive airway pressure (CPAP) devices exist, but there have been concerns that non-invasive ventilation may expose healthcare workers to infection from aerosolized dispersion of SARS-CoV-2. We propose to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria. Methods The study will occur in 4 stages: (1) convene a Steering Committee of key stakeholders and recruit implementation sites; (2) use the integrated Promoting Action on Research Implementation in Health Services (i-PARiHS) framework to guide a needs assessment of treatment centers’ capacity to use high-flow oxygen therapy to treat COVID-19 patients and utilize the findings to develop an implementation strategy for the use of a CPAP/O2 helmet solution; (3) build infrastructure to support training and data monitoring processes and to develop implementation protocols to evaluate the adaptability of the strategy for the use of the CPAP/O2 helmet; and (4) train health workers, distribute a CPAP/O2 helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of SARS-CoV-2 infection among healthcare workers. Discussion The CPAP/O2 helmet solution for non-invasive ventilation in Nigeria can serve as a scalable model for resource-poor countries, and beyond the COVID-19 pandemic, has the potential to be deployed for the treatment of pneumonia and other respiratory diseases. Trial registration NCT04929691. Registered June 18, 2021—retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04929691

PVP1—The People’s Ventilator Project: A fully open, low-cost, pressure-controlled ventilator research platform compatible with adult and pediatric uses

“…The patient does not need to be sedated to use a CPAP, as they just involve a mask on the face. However, while CPAP machines are excellent instruments for ventilation [ 8 ], they cannot sustain high pressures like more invasive ventilators can, and thereby cannot sustain patients in more critical conditions. Critical COVID-19 patients’ lungs become stiffer and ultimately an invasive ventilator is required.…”

Implementation of a Non-Invasive Helmet Ventilation Solution for the Management of Severe COVID-19 Respiratory Disease in Nigeria: The CircumVent Project

“…A total of 156 CPAP/O2 helmet ventilator kits were delivered to the treatment centers. The CPAP/O2 helmet kits included 22-mm tubing and viral filters for the patient circuit with valves for supplemental oxygen (8). The patient interface is a low-cost subsalve oxygen helmet used in combination with disposable inspiratory and expiratory 22-mm filters, intended to protect healthcare workers from aerosolized viral exposure.…”

“…Patients were treated with CPAP/O2 helmet based on disease severity and protocol (www.circumventproject.com/protocol). We used a mixed-methods design (8) to address the three study objectives; and utilized the Integrated Promoting Action on Research Implementation Services (iPARIHS) framework to guide program implementation (16). In order to assure buy-in from the treatment centers and Nigeria's Federal Ministry of Health, we convened a steering committee of key stakeholders across the health sector to provide guidance on implementation strategy.…”

“…Advantages of CPAP/O2 helmet NIV include 1) using low-cost, widely available CPAP devices (1% the cost of a mechanical ventilator); 2) limiting viral dispersion, including potential aerosolization of SARS-CoV-2 by helmet-based filtration; 3) delivering oxygen effectively in part due to positive end-expiratory pressure (PEEP) at relatively low oxygen flow rates, (compared to high oxygen flow using nasal cannula and other forms of NIV), which addresses oxygen scarcity (1,(5)(6)(7)(8)(9)(10). Additionally, while data are limited, CPAP/O2 helmet ventilation may have advantages over high flow nasal oxygen, and avoid the need for scarce mechanical ventilation (1,9,11).…”

Oxygen as an Essential Medicine

“…The Circumvent Project in Nigeria is examining helmet noninvasive ventilation using an implementation science framework. 59 These studies, and others, are crucial to improving our understanding of how to best deliver supplemental oxygen in an efficient manner while accounting for the unique context of health care institutions in LMICs.…”