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Author Notes:

André A. Fenton, Email: af95@nyu.edu

AA, AF, AS, OGO, IO, BS, OE, AH, and MHA conceived and designed the study. AA, IO, and AM analyzed the data. MHA, AF, BS, IO, AH, and OGO applied for and secured funding for the study. BM, NN, SA, CF, AD, AA, MS, AO, MR, and OO contributed to the data collection. AS, IO, BM, and AA led the design and implementation of the clinical training component. All authors contributed to the data interpretation. MA, OO, IO, and AA drafted the initial versions of the article. All authors made major contributions to the writing and critical revision of the manuscript. All authors read and approved the final submitted version.

We are grateful to the 40+ volunteers who worked to develop the concept of the CPAP/O2Helmet system within the Ventilator Project (www.ventilatorproject.org), especially John Gridley who guided and helped the team to navigate the medical device and funding spaces and Deepika Grover who helped with communications and the search for funding.

AH is a founder and AAF is an advisor to Ventilator Project LLC.

Subjects:

Research Funding:

This study is made possible by support from the CDC Foundation award number 1085.1 and the Aliko Dangote Foundation grant number GS2008-0001. The findings and conclusions are those of the authors and do not necessarily represent the official position of the CDC Foundation or the Aliko Dangote Foundation.

Keywords:

  • Implementation science
  • Nigeria
  • Non-invasive ventilation
  • SARS-CoV-2, COVID-19 infection

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

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Journal Title:

Implement Sci Commun

Volume:

Volume 2, Number 1

Publisher:

, Pages 93-93

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© The Author(s) 2021

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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