Suzumura Erica Aranha, Zazula Ana Denise, Moriya Henrique Takachi, Fais Cristina Quemelo Adami, Alvarado Alembert Lino, Cavalcanti Alexandre Biasi, Rodrigues Ricardo Goulart
Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), Brasil.
Faculdade de Medicina, Pontifícia Universidade Católica do Paraná - Curitiba (PR), Brasil.
Rev Bras Ter Intensiva. 2020 Jul-Sep;32(3):444-457. doi: 10.5935/0103-507X.20200075.
The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators' shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.
新冠疫情引发了管理者、医疗专业人员以及普通民众对重症患者可能出现机械通气设备短缺的担忧。在巴西，有多项举措旨在生产替代通气设备以填补这一缺口。为帮助参与这些举措的团队，我们对生理学和呼吸力学的一些基本概念、常用的机械通气术语、触发与切换的区别、基本通气模式以及其他相关方面进行了讨论，这些方面包括呼吸机诱发肺损伤的机制、呼吸驱动、气道加热与加湿、交叉污染风险和气溶胶传播。在原型开发阶段之后，需要按照最低技术要求进行临床前台架测试和动物模型试验，以确定通气设备的安全性和性能。接下来，必须按照巴西卫生监管机构（国家卫生监督局 - ANVISA）的要求履行监管程序。制造公司应由ANVISA进行适当注册，在研究伦理委员会批准研究方案后，还必须将临床试验的开展情况通知ANVISA。向ANVISA注册通气设备的申请应包括一份档案，其中包含本文所述的信息，本文并非旨在涵盖所有相关事项，而是为所需程序提供指导。
