key: cord-0987945-ht71fnd5 authors: Pons-Òdena, Marti; Valls, Arnau; Grifols, Jordi; Farré, Ramon; Lasosa, Francico Jose Cambra; Rubin, Bruce K. title: COVID-19 and respiratory support devices date: 2020-06-20 journal: Paediatr Respir Rev DOI: 10.1016/j.prrv.2020.06.015 sha: 6c0b2622d3b715fc6a05f5b94598960329701aad doc_id: 987945 cord_uid: ht71fnd5 There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused. COVID-19 and respiratory support devices There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among coun-tries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused. The reader will appreciate that:  Reallocation of resources is needed to supply essential medical equipment during an epidemic outbreak. The development and use of emergency devices for respiratory support is a complex interaction between healthcare providers, patients, and the respiratory support devices. It is essential to implement appropriate procedures to rapidly evaluate new medical devices; including the testing and training using animal models that replicate human disease.  In low-middle income countries, due to the scarcity of CPAP devices or ventilators, conducting clinical studies with novel COVID-19 emergency devices could contribute to saving lives. 1. To reassess the management of respiratory failure with affordable and straightforward devices to provide both non-invasive and invasive support. To evaluate the most effective and efficient ways to train healthcare providers from diverse settings to understand and correctly use novel devices. The experience in caring for hospitalized children with COVID-19 in Barcelona, like in many other places, has fortunately been very limited. This allowed us to support and initiate projects developing respiratory support devices in our region. At the beginning of the outbreak, there was an alarming message regarding the potential need for thousands of ventilators. In areas with the highest impact of the outbreak, the number of intensive care unit [ICU] beds multiplied threefold. This article shares strategies implemented in Catalonia, Spain, to provide respiratory support to the vast number of adult patients admitted to our hospitals with respiratory failure. Initially, many hospitals were able to convert operating rooms and general wards into ICUs using anaesthetic ventilators, transport ventilators, and older ventilators coming from laboratories or teaching simulation areas. Non-invasive ventilators have also been used transiently as invasive ventilators in pressure-controlled modes. However in some hospitals, these resources were rapidly exhausted. In Spain, the National government provides most of the healthcare resources and the regional authorities regulate their use. Catalonia is situated in the North East corner of the country, with Barcelona as its capital. The local government undertook several key initiatives as listed in Tables 1 and 2 . There are significant logistical challenges to providing respiratory support devices, Even though some of these devices may become available, there is no guarantee that they will provide optimal ventilation. Especially for invasive ventilation, the need for an appropriate environment with a trained staff is crucial to good outcomes. Indeed, clinical experience in Bangladesh, having an 80% mortality in pneumonia patients mechanically ventilated in the PICU, prompted a RCT (7) which showed superior results using the simplicity and safety of bubble CPAP, a device that can be built locally at low cost (8) . Most teams of engineers, who did not have biomedical backgrounds, concentrated on developing simple respiratory devices based on resuscitation bags requiring positive end-expiratory pressure (PEEP) valves. Companies with medical device experience, or academic centres, developed respiratory devices fulfilling most requirements for the device to be properly called a ventilator. Mechanical Ventilator University centres and companies from Italy, Canada and the USA (9). It is important to stress that new devices should initially be evaluated in a physiology laboratory using a lung simulator. In our case, most were evaluated at the with an external PEEP valve, we found that condensed humidity induced by respiration affected the behaviour of the PEEP valve, a phenomenon that could compromise patient oxygenation. Moreover, inappropriate settings can generate rebreathing or auto PEEP, which is a problem that can be missed in the laboratory but is easily identified by blood gas measurements in the animal during the in vivo testing procedure. Importantly, each new emergency device will also require its own troubleshooting checklist which are likely different from those used for conventional ventilators available in hospitals. Therefore, it is crucial to have a clinician's guidance based on the problems observed in the laboratory and in the simulation with animals. No matter how acute the anxiety generated by the lack of ventilators is, connecting a patient to an insufficiently tested device may lead to morbidity which could be worse than not using the device at all. Additionally, a certification laboratory should assess safety issues and electromagnetic compatibility, similar to those required to get the CE label. Fortunately, even at the peak of the epidemic, the newly developed ventilators were not required for clinical use. Hence, checking their clinical performance in Spain was not possible as there was no ethical reason to justify this. We do have a unique opportunity to learn whether some of these relatively inexpensive and simpler COVID-19 inspired devices could play a role in low-middle income countries where mechanical ventilators are in short supply or simply unavailable. As mentioned before, ventilator support is not only a matter of having devices available. In Formula-1 racing it is possible to finish a race with only one car and driver. Nevertheless, to compete for the world championship requires having a seasoned driver, replacement car(s), and a support team trained with engineers, mechanics for maintenance, and the availability of spare parts for repairs. Providing effective mechanical ventilation therapy also requires a multi-disciplinary, well-trained team including health care staff and technical support people able to service the equipment. It is time to offer more than oxygen from the concentrator, or low-cost devices to improve the outcome of respiratory failure in developing countries. Open source technology publication (11), co-creation design approaches involving local partners (8) and training modules for on-site healthcare workers, technicians, and engineers are needed to make a difference, which with sufficient commitment globally could finally bring about long-term improvements. The future: Low-middle income countries moving beyond oxygen Protecting healthcare workers from SARS-CoV-2 infection: practical indications Low-cost, easy-tobuild non-invasive pressure support ventilator for under-resourced regions: open source hardware description, performance and feasibility testing Early consensus management for non-ICU acute respiratory failure SARS-CoV-2 emergency in Italy: from ward to trenches Can you deliver accurate tidal volume by manual resuscitator? Artificial ventilation during transport: A randomized crossover study of manual resuscitators with comparison to mechanical ventilators in a simulation model Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial Novel Approach for Providing Pediatric Continuous Positive Airway Pressure Devices in Low-Income, Underresourced Regions Near-Apneic Ventilation Decreases Lung Injury and Fibroproliferation in an Acute Respiratory Distress Syndrome Model with Extracorporeal Membrane Oxygenation A review of open source ventilators for COVID-19 and future pandemics Companies were asked to urgently develop new devices to provide respiratory support.Home ventilation providers assembled home ventilators from their available supplies for hospital use. Patients not using their home CPAP devices had their devices redeployed to the hospitals for acute care.Companies were asked to provide oxygen to hotels that had been temporarily converted into convalescence hospitals and care units for mild patients.Veterinarians were asked to lend their ventilators, commonly old-fashioned, for human use, to be used for acutely ill patients.