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

Aimalohi A Ahonkhai, Adesola Z Musa, André A Fenton, Muktar H Aliyu, Igho Ofotokun, Alex Hornstein, Baba M Musa, Nnamdi Nwosu, Ifeoma Ulasi, Samuel Ajayi, Catherine Falade, Adedamola Dada, Aliyu Abdu, Mogaji Sunday, Adenike Odewabi, Muyiwa K Rotimi, Onome Ogueh, Alan Steinbach, Gbenga Ogedegbe, Babatunde L Salako, Oliver C Ezechi, Aimalohi A Ahonkhai, Adesola Z Musa, André A Fenton, Muktar H Aliyu, Igho Ofotokun, Alex Hornstein, Baba M Musa, Nnamdi Nwosu, Ifeoma Ulasi, Samuel Ajayi, Catherine Falade, Adedamola Dada, Aliyu Abdu, Mogaji Sunday, Adenike Odewabi, Muyiwa K Rotimi, Onome Ogueh, Alan Steinbach, Gbenga Ogedegbe, Babatunde L Salako, Oliver C Ezechi

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://ichgcp.net/clinical-trials-registry/NCT04929691.

Keywords: Implementation science; Nigeria; Non-invasive ventilation; SARS-CoV-2, COVID-19 infection.

Conflict of interest statement

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

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Patient circuit 1. Non-invasive positive pressure ventilation
Fig. 2
Fig. 2
Timeline of project activities

References

    1. WHO. Weekly epidemiological update - 15 June 2021. Emergency situational updates. Accessed June 20, 2021.
    1. Cabore JW, Karamagi HC, Kipruto H, Asamani JA, Droti B, Seydi ABW, Titi-Ofei R, Impouma B, Yao M, Yoti Z, Zawaira F, Tumusiime P, Talisuna A, Kasolo FC, Moeti MR. The potential effects of widespread community transmission of SARS-CoV-2 infection in the World Health Organization African Region: a predictive model. BMJ Glob Health. 2020;5(5):e002647. doi: 10.1136/bmjgh-2020-002647.
    1. Beitler JR, Owens RL, Malhotra A. Unmasking a role for noninvasive ventilation in early acute respiratory distress syndrome. JAMA. 2016;315(22):2401–2403. doi: 10.1001/jama.2016.5987.
    1. Brambilla AM, Aliberti S, Prina E, Nicoli F, Forno MD, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014;40(7):942–949. doi: 10.1007/s00134-014-3325-5.
    1. Chiumello D, Brochard L, Marini JJ, et al. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017;21(1):1–8. doi: 10.1186/s13054-017-1820-0.
    1. Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guérin C, Schortgen F, Lefort Y, Antonelli M, Lepage E, Lemaire F, Brochard L. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: a randomized controlled trial. JAMA. 2000;284(18):2352–2360. doi: 10.1001/jama.284.18.2352.
    1. MSHS. Repurposing bi-level ventilators for use with intubated patients while minimizing risk to health care works during insufficient supply of conventional ventilation for patients with COVID-19. 2020; . Accessed July 5, 2020.
    1. MSHS. COVID-19 Research Guidance for MSHS. 2020; . Accessed June 29, 2020.
    1. Liu Q, Gao Y, Chen R, Cheng Z. Noninvasive ventilation with helmet versus control strategy in patients with acute respiratory failure: a systematic review and meta-analysis of controlled studies. Crit Care. 2016;20(1):265. doi: 10.1186/s13054-016-1449-4.
    1. Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized clinical trial. JAMA. 2016;315(22):2435–2441. doi: 10.1001/jama.2016.6338.
    1. Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2015;11(1):33. doi: 10.1186/s13012-016-0398-2.
    1. Allen CG, Brownstein JN, Satsangi A, Escoffery C. Community health workers as allies in hypertension self-management and medication adherence in the United States, 2014. Prev Chronic Dis. 2016;13:e179. doi: 10.5888/pcd13.160236.
    1. New York State Registered Disinfectants Based on EPA List Accessed June 20, 2021.
    1. Simonds A, Hanak A, Chatwin M, Morrell M, Hall A, Parker KH, Siggers JH, Dickinson RJ. Evaluation of droplet dispersion during non-invasive ventilation, oxygen therapy, nebuliser treatment and chest physiotherapy in clinical practice: implications for management of pandemic influenza and other airborne infections. Health Technol Assess. 2010;14(46):131–172. doi: 10.3310/hta14460-02.
    1. Hui D, Chow B, Lo T, Tsang O, Ko F, Ng S. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019;53(4):1802339. doi: 10.1183/13993003.02339-2018.
    1. Hui DS, Chow BK, Lo T, Ng SS, Ko FW, Gin T, Chan MTV. Exhaled air dispersion during noninvasive ventilation via helmets and a total facemask. Chest. 2015;147(5):1336–1343. doi: 10.1378/chest.14-1934.
    1. Fryar CD, Ostchega Y, Hales CM, Zhang G, Kruszon-Moran D. Hypertension prevalence and control among adults: United States, 2015-2016. NCHS data brief. 2017;289:1–8.
    1. Calò F, Russo A, Camaioni C, De Pascalis S, Coppola N. Burden, risk assessment, surveillance and management of SARS-CoV-2 infection in health workers: a scoping review. Infect Dis Poverty. 2020;9(1):139. doi: 10.1186/s40249-020-00756-6.
    1. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. doi: 10.1186/s13012-017-0635-3.
    1. Bowling A. Research Methods in Health. 4. Buckingham: Open University Press; 2014.
    1. Braun V, Clarke V, Weate P. Using thematic analysis in sport and exercise research. In: Smith B, Sparkes AC, editors. Routledge handbook of qualitative research in sport and exercise. London: Routledge; 2016. pp. 191–205.
    1. Guest G, Namey E, Chen M. A simple method to assess and report thematic saturation in qualitative research. PLoS One. 2020;15(5):e0232076. doi: 10.1371/journal.pone.0232076.
    1. Moser A, Korstjens I. Series: Practical guidance to qualitative research. Part 3: sampling, data collection and analysis. Eur J Gen Pract. 2018;24(1):9–18. doi: 10.1080/13814788.2017.1375091.
    1. Wonodi C, Obi-Jeff C, Falade A, Watkins K, Omokore OA. Pneumonia in Nigeria: the way forward. Pediatr Pulmonol. 2020;55(Suppl 1):S5–S9.

Source: PubMed

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