key: cord-1025582-vw2wdwmt
authors: Alves Filho, Wellington
title: Authors’ reply to: Comment on the article by Dr. T.Huda: Barrier device prototype for open tracheotomy during COVID-19 pandemic
date: 2020-07-17
journal: Auris Nasus Larynx
DOI: 10.1016/j.anl.2020.07.015
sha: c28aa23d1dbe6b49d64f8ac846eabc0f5f572e5b
doc_id: 1025582
cord_uid: vw2wdwmt

nan

Firstly, thank you in advance for you interest in our article entitled "Barrier Device Prototype for open tracheotomy during COVID-19 pandemic [1] ". We are glad to hear that our device has been used by many other institutions elsewhere, helping to provide a safer environment for surgical procedures involving the airways.

Our prototype was not developed to substitute by any means to replace the adequate equipment and procedures considered as optimal for performing tracheotomy. Rather than that, we strongly believe that the COVID-Box should be considered as an improvement to this optimal setting that has been thoroughly advised in previous articles.

Regarding proper validation prior to the use of devices that could minimize risk of infection, as a quality improvement safety initiative, formal institution review board review was not required per our institution's human research protection guidelines. Other groups have tried similar barrier-devices prior to full external validation [2] . Anyhow, we have stated clearly in our work that further tests on efficacy may be necessary, including those on distribution of aerosolised particles.

Regarding the access ports, since they are made into the 90 g/m 2 malleable plastic sheet, no damage or disrupt of PPEs worn by health staff can be observed. Nevertheless, we recommend not taking the hands out of the device during the procedure, therefore all equipment necessary (clamps, scissors, scalpel, suction tubes, drapes, tracheotomy tube, connections, etc.) should be place on top of patients over sterile surgical field BEFORE placing the sterile COVID-Box apparatus. The whole setting of the procedure itself may increase time BEFORE incision. However, once all equipment are all set and all personnel are positioned, the procedure duration does not take longer than regular open tracheotomy (approximately 10 min of duration). Reconnection to the ventilator is performed inside the COVID-Box perimeter, with the aid of regular connections already placed into the apparatus prior to the procedure also. We recommend leaving the box for three hours, since some particles can be aerosolized for up to 3-hours following manipulation [3] . Functioning suction tubes are still placed inside the box during this period, which can possibly speed up this process. In case of necessary patient manipulation within the 3-hours suggested time, we recommend using the access ports to do so, leaving the apparatus for longer period in this case.

Final concerns include vision impairment and limited dexterity due to an extra layer of complexity caused by the barrier and PPEs. The fully transparent plastic sheet does not affect visibility by any means. Since they are single use only, newer sheets provide better surgical field vision. Our hospital is an academic institution, therefore only experienced surgeons have joined our task force created to handle tracheotomies during the pandemic. Thus, even with added layers of protection, dexterity does not represent a caveat for our team.

We would like to end this letter by saying that our institution does not have any interest on releasing new technologies without full understanding on how it works. However, in light of the pandemic, the continuous search for more affordable means of protecting health care workers is of high importance. In poorer countries like Brazil, where the majority of the population are solely assisted by the public health system, an apparatus like our may contribute on helping surgeons to keep performing necessary tracheotomies, without jeopardizing safety.

Sincerely,

Barrier device prototype for open tracheotomy during COVID-19 pandemic

Negative-pressure aerosol cover for COVID-19 tracheostomy. JAMA otolaryngology -head and neck surgery

COVID-19 may transmit through aerosol