Post-Graduate Program in Health Promotion, Universidade de Santa Cruz do Sul, Santa Cruz do Sul, RS, Brazil.
Multiprofessional Residency Health Program, Hospital Santa Cruz, Santa Cruz do Sul, RS, Brazil.
Trials. 2022 Mar 18;23(1):218. doi: 10.1186/s13063-022-06133-y.
Non-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).
To 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.
A 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 PaO/FiO ratio and PaCO 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.
This 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.
Brazilian Registry of Clinical Trials (ReBEC): RBR - 7xmbgsz . Registered on 15 April 2021.
无创通气（NIV）可用于避免气管插管（OTI），以缩短住院时间并降低死亡率。感染 SARS-CoV2 的患者可能会发展为呼吸衰竭（RF）；然而，在初始阶段，他们可以接受氧疗和 NIV。这些资源会产生气溶胶，从而对卫生专业人员造成高度传染风险。因此，正在寻求安全的 NIV 策略，作者为此将潜水面罩改装成 NIV 面罩（称为“Ownermask”）。
评估 Ownermask 相对于传统口鼻面罩在有或无 COVID-19 确诊或疑似的呼吸衰竭患者中的安全性和有效性。
巴西多中心研究，评估入住重症监护病房的患者的临床、社会人口学和人体测量数据。主要结局将是气管插管率，次要结局将包括院内死亡率、PaO/FiO 比值和 PaCO 水平的差异、重症监护病房和住院时间、不良反应、面罩使用舒适度和满意度程度、NIV 成功率（未进展为 OTI），以及使用 Ownermask 和传统面罩进行 NIV 时通气变量的行为。有 COVID-19 且有 RF 临床指征的患者将接受 Ownermask 进行 NIV[NIV Ownermask COVID 组（n=63）]或传统口鼻面罩进行 NIV[NIV 口鼻面罩 COVID 组（n=63）]，因与 COVID-19 无关的原因而患有 RF 的患者将以随机方式分配到 NIV Ownermask Non-COVID 组（n=97）或 NIV 口鼻面罩 Non-COVID 组（n=97），共计 383 例患者，预计 20%会失访。
这是 COVID-19 大流行期间关于 Ownermask 与传统口鼻面罩安全性和有效性的首次随机对照试验。实验研究表明，Ownermask 可在患者面部实现适当密封，而本研究具有相关性，因为其旨在最大限度地减少环境中病毒的气溶胶化并提高卫生专业人员的安全性。
巴西临床试验注册处（ReBEC）：RBR-7xmbgsz。于 2021 年 4 月 15 日注册。
