https://doi.org/10.4081/monaldi.2023.2512
Does the use of a diving mask adapted for non-invasive ventilation in hypoxemic acute respiratory failure in individuals with and without COVID-19 increase the ratio of arterial oxygen partial pressure to fractional inspired oxygen? A randomized clinical trial
Submitted: December 30, 2022
Accepted: May 4, 2023
Published: May 24, 2023
Accepted: May 4, 2023
Abstract Views: 489
PDF: 186
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Non-invasive ventilation (NIV) can be used in acute hypoxemic respiratory failure (AHRF); however, verifying the best interface for its use needs to be evaluated in the COVID-19 pandemic scenario. The objective of this study was to evaluate the behavior of the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) in patients with AHRF with and without COVID-19 undergoing NIV with the conventional orofacial mask and the adapted diving mask. This is a randomized clinical trial in which patients were allocated into four groups: i) group 1: COVID-19 + adapted mask (n=12); ii) group 2: COVID-19 + conventional orofacial mask (n=12); iii) group 3: non-COVID-19 + adapted mask (n=2); iv) group 4: non-COVID-19 + conventional orofacial mask (n=12). The PaO2/FiO2 ratio was obtained 1, 24, and 48 hours after starting NIV, and the success of NIV was evaluated. This study followed the norms of the Consolidated Standards of Reporting Trials statement and was registered in the Brazilian Registry of Clinical Trials under registration RBR-7xmbgsz. Both the adapted diving mask and the conventional orofacial mask increased the PaO2/FiO2 ratio. The interfaces differed in terms of the PaO2/FiO2 ratio in the first hour [309.66 (11.48) and 275.71 (11.48), respectively] (p=0.042) and 48 hours [365.81 (16.85) and 308.79 (18.86), respectively] (p=0.021). NIV success was 91.7% in groups 1, 2, and 3, and 83.3% in group 4. No adverse effects related to interfaces or NIV were observed. NIV through the conventional orofacial mask interfaces and the adapted diving mask was effective in improving the PaO2/FiO2 ratio; however, the adapted mask presented a better PaO2/FiO2 ratio during use. There was no significant difference between interfaces regarding NIV failure.
Scala R, Heunks L. Highlights in acute respiratory failure. Eur Respir Rev 2018;27:180008.
Ferreyro BL, Angriman F, Munshi L, et al. Association of noninvasive oxygenation strategies with all-cause mortality in adults with acute hypoxemic respiratory failure: a Systematic Review and Meta-analysis. JAMA 2020;324:57-67.
Xu XP, Zhang XC, Hu SL, et al. Noninvasive ventilation in acute hypoxemic nonhypercapnic respiratory failure: a systematic review and meta-analysis. Crit Care Med 2017;45:e727-33.
Guan WJ, Zheng YN, Yu H, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:1708-20.
Winck JC, Scala R. Non-invasive respiratory support paths in hospitalized patients with COVID-19: proposal of an algorithm. Pulmonology 2021;27:305-12.
Wang P, Liu L, Iketani S, et al. Increased resistance of SARS-CoV-2 variants B.1.351 and B.1.1.7 to antibody neutralization. Res Sq 2021;rs.3.rs:155394.
Vergano M, Bertolini G, Giannini A, et al. Clinical ethics recommendations for the allocation of intensive care treatments in exceptional, resource-limited circumstances: the Italian perspective during the COVID-19 epidemic. Crit Care 2020;24:165.
Spina S, Marrazzo F, Migliari M, et al. The response of Milan’s emergency medical system to the COVID-19 outbreak in Italy. Lancet 2020:e49-50.
Gómez CC, Rodríguez P, Torné ML, et al. Clinical consensus recommendations regarding non-invasive respiratory support in the adult patient with acute respiratory failure secondary to SARS-CoV-2 infection. Rev Esp Anestesiol Reanim 2020;67:261-70.
Germonpre P, Rompaey DV, Balestra C. Evaluation of protection level, respiratory safety, and practical aspects of commercially available snorkel masks as personal protection devices against aerosolized contaminants and SARS-CoV2. Int J Environ Res Public Health 2020;17:4347.
Lazzeri M, Lanza A, Bellini R, et al. Respiratory physiotherapy in patients with COVID-19 infection in acute setting: a position paper of the Italian Association of respiratory physiotherapists (ARIR). Monaldi Arch Chest Dis 2020;90:1285.
Ñamendys-Silva SA. Respiratory support for patients with COVID-19 infection. Lancet Respir Med 2020;8:e18.
Bibiano-Guillen C, Arias-Arcos B, Collado-Escudero C. Adapted diving mask (ADM) device as respiratory support with oxygen output during COVID-19 pandemic. Am J Emerg Med 2021;39:42-7.
Charron C, Repesse X, Bouferrache K, et al. PaCO2 and alveolar dead space are more relevant than PaO2/FiO2 ratio in monitoring the respiratory response to prone position in ARDS patients: a physiological study. Crit Care 2011;15:R175.
Feiner JR, Weiskopf RB. Evaluating pulmonary function: an assessment of PaO2/FIO2. Crit Care Med 2017;45:e40-8.
Colaneri M, Sacchi P, Zuccaro V, et al. Clinical characteristics of coronavirus disease (COVID-19) early findings from a teaching hospital in Pavia, North Italy, 21 to 28 February 2020. Euro Surveill 2020;25:2000460.
Zinellu A, De Vito A, Scano V, et al. The PaO2/FiO2 ratio on admission is independently associated with prolonged hospitalization in COVID-19 patients. J Infect Dev Ctries 2021;31:353-59.
Dainesi SM, Aligieri P. Como as recomendações CONSORT podem assegurar a qualidade dos relatos de estudos clínicos?. Rev Assoc Med Bras 2005;5:6. [Article in Portuguese].
Mergulhadores do Bem. Apresentação. Available from: https://www.owntec.com.br/mergulhadores/.
Paiva DN, Wagner LE, Marinho SES, et al. Effectiveness of an adapted diving mask (Owner mask) for non-invasive ventilation in the COVID-19 pandemic scenario: study protocol for a randomized clinical trial. Trials 2022;23:218.
Associação de Medicina Intensiva Brasileira (AMIB), Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). Diretrizes Brasileira de Ventilação Mecânica, 2013. Available from: https://cdn.publisher.gn1.link/jornaldepneumologia.com.br/pdf/Cap_Suple_91_01.pdf. Accessed on: 20/04/2023. [Material in Portuguese].
Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury?. Anesthesiology 2007;106:1226-31.
Seiberlich E, Santana JÁ, Chaves RA, Seiberlich RC. Ventilação mecânica protetora, por que utilizar?. Rev Bras Anestesiol 2011;61:659-67. [Article in Portuguese].
Mitchell CO, Lipschitz DA. Arm length measurement as an alternative to height in nutritional assessment of the elderly. JPEN J Parenter Enteral Nut 1982;6:226-9.
Araújo MLD, Andrade MLSS, Prado LVS et al. Precisão do IMC em diagnosticar o excesso de gordura corporal avaliada pela bioimpedância elétrica em universitários. Nutr Clín Diet Hosp 2018;38:154-60. [Article in Portuguese].
Borg G. Physiological bases of perceived exertion. Med Sci Sports Exerc 1982;14:377-81.
Cabral LL, Lopes PB, Wolf R, et al. A systematic review of cross-cultural adaptation and validation of Borg´s rating of perceived exertion scale. J Phys Educ 2017;28:e2853.
Holanda MA, Reis RC, Winkeler GFP, et al. Influence of total face, facial and nasal masks on short-term adverse effects during noninvasive ventilation. J Bras Pneumol 2009;35:164-73. [Article in Portuguese].
Coia, JE, Ritchie L, Adisesh A, et al. Guidance on the use of respiratory and facial protection equipment. J Hosp Infect 2013;85:170-82.
Kroo L, Kothari A, Hannebelle M, et al. Pneumask modified full-face snorkel masks as reusable personal protective equipment for hospital personnel. BMJ 2020;4:e20078907.
Wagner LE, Basegio KG, Dornelles CFD, et al. Diving mask adapted for non-invasive ventilation and prone position in a patient with severe covid-19: case report. Rev Epidemiol Control Infect 2020;10:15402.
Chaudhuri D, Jinah R, Burns KEA, et al. Helmet non-invasive ventilation compared to facemask non-invasive ventilation and high flow nasal cannula in acute respiratory failure: a systematic review and meta-analysis. Eur Resp J 2022;59:2101269.
Wang, K,Wei Z, Li J, et al. The experience of high-flow nasal cannula in hospitalized patients with 2019 novel coronavirus-infected pneumonia in two hospitals of Chongqing, China. Ann Intensive Care 2020;10:37.
Associação de Medicina Intensiva Brasileira (AMIB). Orientações sobre o manuseio do paciente com pneumonia e insuficiência respiratória devido a infecção pelo coronavírus (SARS-CoV-2) - Versão n.05/2020*. Available from: https://portaldeboaspraticas.iff.fiocruz.br/wp-content/uploads/2020/06/vm_ai_vjs_v5_abr_2020_final.pdf. Accessed on: 20/04/2023. [Material in Portuguese].
Anka AU, Tahir MI, Abubakar SD, et al. Coronavirus disease 2019 (COVID-19): an overview of the immunopathology, serological diagnosis and management. Scand J Immunol 2021;93:e12998.
Burton-Papp HC, Jackson AIR, Beecham R, et al. Conscious prone positioning during non-invasive ventilation in COVID-19 patients: experience from a single centre. F1000Res 2020;9:859.
Ashish A, Unsworth A, Martindale J. CPAP management of COVID-19 respiratory failure: a first quantitative analysis from an inpatient service evaluation. BMJ Open Resp Res 2020;7:e000692.
Sartini C, Tresoldi M, Scarpellini P, et al. Respiratory parameters in patients with COVID-19 after using noinvasive ventilation in the prone position outside the intensive care unit. JAMA 2020;323:2338-40.
Menzela F, Barbieri C, Fornatana M, et al. Effectiveness of noninvasive ventilation in COVID 19 related-acute respiratory distress syndrome. Clin Respir J 2021;15:779-87.
Nightingale R, Nwosu N, Kutubudin F, et al. Is continuous positive airway pressure (CPAP) a new standard of care for type 1 respiratory failure in COVID-19 patients? A retrospective observational study of a dedicated COVID-19 CPAP service. BMJ Open Resp Res 2020;7:e000639.
Burns GP, Lane ND, Tedd HM, et al. Improved survival following ward-based non-invasive pressure support for severe hypoxia in a cohort of frail patients with COVID-19: retrospective analysis from a UK teaching hospital. BMJ Open Resp Res 2020;7:e000621.
Pierucci P, Portacci A, Carpagno GE, et al. The right interface for the right patient in noninvasive ventilation: a systematic review. Exp Rev Respir Med 2022;16:931-44.
Ethics Approval
The study protocol was approved by the Research Ethics Committee and the National Research Ethics Committee (CAAE: 30783720.7.0000.5343, opinion no. 4.305.813, dated 2020/09/29).How to Cite
Marinho, Sônia Elvira dos Santos, Dulciane Nunes Paiva, Guacyra Magalhães Pires Bezerra, Thayse Neves dos Santos Silva, Cláudia Regina Oliveira de Paiva Lima, Maria Cristina Falcão Raposo, and Patrícia Érika de Melo Marinho. 2023. “Does the Use of a Diving Mask Adapted for Non-Invasive Ventilation in Hypoxemic Acute Respiratory Failure in Individuals With and Without COVID-19 Increase the Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen? A Randomized Clinical Trial”. Monaldi Archives for Chest Disease 94 (1). https://doi.org/10.4081/monaldi.2023.2512.
Copyright (c) 2023 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
