ATENA-A Novel Rapidly Manufactured Medical Invasive Ventilator Designed as a Response to the COVID-19 Pandemic: Testing Protocol, Safety, and Performance Validation.

Background: The urgent need for mechanical ventilators to support respiratory insufficiency due to SARS-CoV-2 led to a worldwide effort to develop low-cost, easily assembled, and locally manufactured ventilators. The ATENA ventilator project was developed in a community-based approach targeting the development, prototyping, testing, and decentralized manufacturing of a new mechanical ventilator. Objective: This article aims to demonstrate ATENA's adequate performance and safety for clinical use. Material: ATENA is a low-cost ventilator that can be rapidly manufactured, easily assembled, and locally produced anywhere in the world. It was developed following the guidelines and requirements provided by European and International Regulatory Authorities (MHRA, ISO 86201) and National Authorities (INFARMED). The device was thoroughly tested using laboratory lung simulators and animal models. Results: The device meets all the regulatory requirements for pandemic ventilators. Additionally, the pre-clinical experiences demonstrated security and adequate ventilation and oxygenation, in vivo. Conclusion: The ATENA ventilator had a good performance in required tests in laboratory scenarios and pre-clinical studies. In a pandemic context, ATENA is perfectly suited for safely treating patients in need of mechanical ventilation.

The Role of Locoregional Anesthesia in the COVID-19 Pandemic

Coronavirus disease 2019 (COVID-19) refers to the respiratory tract infection caused by the newly emergent coronavirus SARS-CoV-2. The present pandemic, declared on the 11th of March 2020, was first recognized in Wuhan city, and rapidly spread throughout China and other countries, including Portugal. Regional anesthesia should be considered whenever surgery is planned for a patient with suspected or confirmed COVID-19, as it minimizes not only airway management, the intervention with the highest risk of aerosolization, but also potential personnel contamination and patient recovery time, while maximizing operation room efficiency. Anesthesia techniques should be aimed at preventing airway manipulation such as endotracheal intubation, which is associated with a higher risk of pulmonary complications in infected patients. These recommendations are structured in pre-, intra-, and post-operative management in suspected or confirmed infected patients with SARS-CoV-2, based in local hospital infection committee recommendations and the most recent literature available regarding regional anaesthesia. They are aimed at anesthesiology personnel, with the main goals being both team and patient safety. The SARS-CoV-2 virus will be not the last novel virus to trigger global pandemics, so having a well-structured regional anesthesia plan to manage this kind of cases will ensure the best outcome possible to both patients and the perioperative team.