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

Abstract

BackgroundNon-invasive ventilation (NIV) is indicated to avoid orotracheal intubation (OTI) to reduce hospital stay and mortality. Patients infected by SARS-CoV2 can progress to respiratory failure (RF); however, in the initial phase, they can be submitted to oxygen therapy and NIV. Such resources can produce aerosol and can cause a high risk of contagion to health professionals. Safe NIV strategies are sought, and therefore, the authors adapted diving masks to be used as NIV masks (called an Owner mask).ObjectiveTo assess the Owner mask safety and effectiveness regarding conventional orofacial mask for patients in respiratory failure with and without confirmation or suspicion of COVID-19.MethodsA Brazilian multicentric study to assess patients admitted to the intensive care unit regarding their clinical, sociodemographic and anthropometric data. The primary outcome will be the rate of tracheal intubation, and secondary outcomes will include in-hospital mortality, the difference in PaO2/FiO2 ratio and PaCO2 levels, time in the intensive care unit and hospitalization time, adverse effects, degree of comfort and level of satisfaction of the mask use, success rate of NIV (not progressing to OTI), and behavior of the ventilatory variables obtained in NIV with an Owner mask and with a conventional face mask. Patients with COVID-19 and clinical signs indicative of RF will be submitted to NIV with an Owner mask [NIV Owner COVID Group (n = 63)] or with a conventional orofacial mask [NIV orofacial COVID Group (n = 63)], and those patients in RF due to causes not related to COVID-19 will be allocated into the NIV Owner Non-COVID Group (n = 97) or to the NIV Orofacial Non-COVID Group (n = 97) in a randomized way, which will total 383 patients, admitting 20% for loss to follow-up.DiscussionThis is the first randomized and controlled trial during the COVID-19 pandemic about the safety and effectiveness of the Owner mask compared to the conventional orofacial mask. Experimental studies have shown that the Owner mask enables adequate sealing on the patient’s face and the present study is relevant as it aims to minimize the aerosolization of the virus in the environment and improve the safety of health professionals.Trial registrationBrazilian Registry of Clinical Trials (ReBEC): RBR – 7xmbgsz. Registered on 15 April 2021.