key: cord-0735928-f04jve7b authors: Filho, Wellington Alves; Teles, Tulio Sampaio Pontes Grangeiro; da Fonseca, Márcio Ribeiro Studart; Filho, Francisco Januário Farias Pereira; Pereira, Glebert Monteiro; Pontes, Alan Breno Moura; de Paula, Eliane Maria da Silva; Nunes, Andre Alencar Araripe; Ferreira, Luis Alberto Albano title: BARRIER DEVICE PROTOTYPE FOR OPEN TRACHEOTOMY DURING COVID-19 PANDEMIC date: 2020-05-08 journal: Auris Nasus Larynx DOI: 10.1016/j.anl.2020.05.003 sha: c6d16aa1428a7efabef35418899ba947e3dd6e96 doc_id: 735928 cord_uid: f04jve7b ABSTRACT OBJECTIVE To present a low-cost prototype for a barrier enclosure device which can be used during open surgeries such as tracheotomy. METHODS We provide detailed description of a novel device called COVID-Box, developed by The Surgical Airway Team for COVID-19 Pandemic, a temporary task force formed by Walter Cantídio University Hospital. Safety guidelines for performing tracheotomies in COVID-19 patients are also stated. RESULTS Our prototype device provides greater hand mobility than previous barrier devices reported, making it more suitable for airway surgical procedures, such as tracheotomy. The curved shaped format and the customizable access ports provides ergonomics, without compromising safety. CONCLUSION The COVID-Box appears to be an efficient, reproduceable, low-cost barrier enclosure device that can be used for open tracheotomies in ICU patients during the COVID-19 pandemic. Since December 2019 a number of cases of pneumonia have been reported in Wuhan, China, caused by a novel virus from the coronavirus family (1, 2) , the SARS-CoV-2 virus. The coronavirus disease 2019 (abbreviated COVID-19), has rapidly swept across the world (3) , with the World Health Organization (WHO) declaring it a pandemic on March 11. Since then, the SARS-CoV-2 continues to spread internationally, with 2,394,278 of confirmed cases and 164,937 deaths worldwide on April 17 (4) . In Brazil, on the same date, the total confirmed cases were 38,654, with 2,462 deceased (4) . In the state of Ceará, located at the northeastern part of Brazil, the more recent official report showed 3,306 cases confirmed, with 189 deaths, a mortality rate of 5.7%. That brings Ceará to a preoccupying third place, when comparing other states of Brazil, regarding the number of confirmed cases so far (5) . The main transmission mechanism is via respiratory droplets originated from coughing and sneezing, but aerosol transmission is possible, particularly under the condition of long exposure in a relatively closed environment (2, 6) . While respiratory droplets can be spread in a space up to two meters from the source of infection, bioaerosols can travel hundreds of meters (6). Many procedures involving the airways may generate aerosol, raising the risk of infection of the health care staff (7, 8) . Such procedures may include mask ventilation, non-invasive ventilation and tracheotomy (7) . The risk of infection of the health care workers is a major concern. Although head and neck-otolaryngology not being a front-line specialty in dealing with this disease (9), high rates of nosocomial spread were seen amongst otolaryngologists, especially because of the high viral load in the upper respiratory tract (3) . Thus, personal protective equipment (PPE) has become an important subject during the COVID-19 epidemic, which can include fitted high-filtration masks, with its use specially during aerosol generating procedures (10) . Guidelines and recommendations on head and neck evaluation and surgery during the COVID-19 pandemic have been suggested in order to increase safety of health care workers without jeopardizing the care of patients (11) . While the majority of elective surgical head and neck procedures should be postponed, tracheotomy in COVID-19 patients may be considered, especially in patients with prolonged periods of intubation. Tracheotomy is considered a major risk procedure for health care workers, therefore it cannot be overemphasized that barrier precautions are of critical importance (12) . Standard PPEs are essential, but other fundamental aspects include meticulous planning, optimized reduced staff and negative pressure rooms (12) . More recently, a device called "aerosol box" has been suggested to be used as a barrier enclosure during tracheal intubation (13) . It consists of a transparent plastic cube designed to cover a patient's head and that incorporates two circular ports through which the clinician's hands are passed to perform the airway procedure. Despite the fact that it can be The procedure should be performed at bedside in the ICU in order to minimize risks of contamination during transportation. Proper protection of the operative team is paramount during tracheotomy. PPEs for the procedure should include N95 masks, goggles, face shield, surgical gown and double gloves. Surgical team should be limited to two experienced surgeons, with a third person responsible for instrumentation. The removal of the endotracheal tube should be done by ICU staff, also wearing PPEs accordingly. The COVID-Box consist in two parts: (1) a metallic frame which can be sterilized and (2) a sterile disposable transparent plastic sheet, which is used to cover the metallic structure It is also recommended to avoid changing the tracheotomy tube until viral load is low or undetectable (11, 12) . The COVID-19 pandemic brought new challenges to the medical community. As the disease spreads, the pressure on the global health care work force increases. Health care workers are at high risk of exposure, particularly those who perform procedures within the head and neck region and airway (11) . Moreover, the health system capacity is exceeding its limit, especially in poorer countries, where rationing decisions may need to be made (8, 15 ). The importance of PPEs during high risk procedures, such as tracheal intubation and tracheotomy, is undoubtable. Although the widespread use of barrier precautions is highly recommended during patients' care, there is limited availability of N95 masks, respiratory isolation rooms and air-purifying respirators (8) . Such demand is particularly more difficult to manage in a developing country setting. In Brazil, where 74,8% of the population are solely assisted by the public health system, a shortage of ICU beds is expected to occur by the end of April in most major cities (16) . The developing of more affordable strategies to mitigate the spread of the pandemic in such scenarios must be of highest priority. At our institution with developed an efficient, reproduceable, low cost barrier enclosure device that can be used for open tracheotomies in ICU patients during the COVID-19 pandemic. Its metallic frame is fully autoclavable, as well as the high grammage plastic sheet used to cover it. Different acrylic prototypes have been recommended for use during tracheal intubation (13) . However, restricted hand movement and higher production costs may be a caveat. Also, those devices were not developed for use during surgical procedures. Our prototype, on the other hand, provides greater mobility, since the plastic sheet is more malleable, when comparing to more rigid structures such as acrylic. The metallic frame has also a curved shape on its sides where surgeons can be positioned closer to the patient without compromising safety, therefore preserving ergonomics. Ports are also fully customizable, since they are made by the surgical team right before the beginning of the operation. There are some limitations of our prototype that need to be addressed. Firstly, the device does not fully enclose the patient. Possible areas of air escape may include the hand ports, as well as the bottom part of the device. Further experiment on aerosol spread while using the COVID-Box is needed, possibly with fluorescent dye (13) . Secondly, the correct time for removal of the device after tracheotomy is uncertain. Previous reports showed that bioaerosols may be in suspension for several hours( 6,14). Therefore, we strongly suggest leaving the box in place after the procedure, removing it only after 3 hours or longer. Perhaps, as other airway procedures should be performed after tracheotomy, such as pulmonary toilet, the device might be left positioned for longer periods. Also, a study comparing a regular open tracheotomy and one using the device may be necessary, maybe applying a comprehensive questionnaire to surgeons. Nevertheless, we found that the duration of the operation was not compromised by the use of the apparatus. Although the COVID-Box was developed for open tracheotomies, other procedures may benefit with the use of the COVID-Box, such as endotracheal intubation, bronchoscopy, upper digestive endoscopy and many others. Some surgical emergencies may also be performed using the device as well, including emergency cricothyroidotomy. Also, cancer patients may have time-sensitive disease with surgical treatments that cannot be postponed for periods longer than a few months. In such cases, we believe that the use of our device could be helpful. Further work should be done to explore the use of COVID-Box for other procedures. The continuous search for more affordable means of protecting health care workers is highly important. For instance, negative pressure rooms and powered air-purifying respirators are some examples of CPEs that are not always available in many public hospitals in many countries (16) . Thus, the use of barrier devices such as our prototype should be considered to improve collective protection for surgical team during COVID-19 pandemics, especially in the setting of public health institutions in developing countries. The COVID-19 pandemic has spread through the world impacting not only patients, but also health care workers, overwhelming the public health system in many ways. Our institution developed a low cost, reproduceable barrier device that can be used during open tracheotomies in COVID-19 patients. Further tests on efficacy may be necessary. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. 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NEJM Hospital Capacity and Operations in the Coronavirus Disease 2019 (COVID-19) Pandemic-Planning for the Demand for hospitalization services for COVID-19 patients in Brazil. medRxiv The authors would like to thank all staff form Clinical Engineering at Walter Cantidio University Hospital who have helped us building the metallic structure of our prototype device. All authors declare no conflict of interests.