key: cord-0730089-rmhvc5n5
authors: Miles, Brett A.; Schiff, Bradley; Ganly, Ian; Ow, Thomas; Cohen, Erik; Genden, Eric; Culliney, Bruce; Mehrotra, Bhoomi; Savona, Steven; Wong, Richard J.; Haigentz, Missak; Caruana, Salvatore; Givi, Babak; Patel, Kepal; Hu, Kenneth
title: Tracheostomy during SARS‐CoV‐2 pandemic: Recommendations from the New York Head and Neck Society
date: 2020-04-20
journal: Head Neck
DOI: 10.1002/hed.26166
sha: 89218c44b26ac5dbc61fdf38095405da247474e7
doc_id: 730089
cord_uid: rmhvc5n5

The rapid spread of SARS‐CoV‐2 in 2019 and 2020 has resulted in a worldwide pandemic characterized by severe pulmonary inflammation, effusions, and rapid respiratory compromise. The result of this pandemic is a large and increasing number of patients requiring endotracheal intubation and prolonged ventilator support. The rapid rise in endotracheal intubations coupled with prolonged ventilation requirements will certainly lead to an increase in tracheostomy procedures in the coming weeks and months. Performing tracheostomy in the setting of active SARS‐CoV‐2, when necessary, poses a unique situation, with unique risks and benefits for both the patient and the health care providers. The New York Head and Neck Society has collaborated on this document to provide guidance on the performance of tracheostomies during the SARS‐CoV‐2 pandemic.

The rapid spread of SARS-CoV-2 in 2019 and 2020 has resulted in a worldwide pandemic. [1] [2] [3] [4] The dramatic proinflammatory effects of SARS-CoV-2 result in a wide variety of clinical presentations; however, severe pulmonary inflammation, effusions and rapid respiratory compromise are a hallmark of this disease. [5] [6] [7] Subsequent pneumonia, acute respiratory distress syndrome and death have been reported not infrequently. The result of this pandemic is a large and increasing number of patients requiring endotracheal intubation and prolonged ventilator support. [8] [9] [10] [11] [12] [13] Certainly, the rapid rise in endotracheal intubations coupled with prolonged ventilation requirements will lead to an increase in tracheostomy procedures in the coming weeks and months. 14, 15 Although a generally well-tolerated and safe procedure, the risks and benefits of tracheostomy in terms of outcomes, pulmonary care and risks to the health care team remain unknown. 16, 17 Fortunately, although not perfect, rapid testing protocols have allowed us to be able to detect active infection in patients who are affected by SARS-CoV-2. [18] [19] [20] [21] What is clear is that the upper aerodigestive tract, the nasopharynx and the trachea harbor a high viral load during the acute stages of the infection. [22] [23] [24] Therefore, performing a tracheostomy in the setting of active SARS-CoV-2, when necessary, poses a unique situation, with unique risks and benefits for both the patient and the health care providers. The risk of this procedure has to be balanced with the known risks of prolonged intubation, primarily tracheal and subglottic stenosis, the management of which can be problematic if significant mucosal injury and subsequent stenosis occur.

The New York Head and Neck Society is a nonprofit organization founded in 1979, which encourages the exchange and advancement of scientific knowledge relative to the management of head and neck cancer and includes several member institu- Certainly, adequate pressure to avoid cuff leakage and aerosolization is critical when managing SARS-CoV-2 patients, but it should be recognized that unnecessarily high cuff pressures are also problematic. The minimum cuff pressure required to create an adequate seal should be individualized for each patient and verified frequently by care providers. Certainly, high peak pressures, or issues with ventilation may make the appropriate cuff pressure a moving target. This is a dynamic process, and frequent adjustments may be indicated depending on ventilation parameters. Prevention of tracheal mucosal pressure necrosis, resulting tracheal and cricoid chondritis and subsequent stenosis is critical in the SARS-CoV-2 population. 25, 26 SARS-CoV-2 testing via the reverse transcriptionpolymerase chain reaction (rt-PCR) detection platform for SARS-CoV-2 and pan-sarbecovirus detection is recommended for all patients who are being considered for tracheostomy. It should be remembered that data surrounding accuracy of the test during the pandemic is forthcoming, and false negatives are a real possibility. 27 In addition, rt-PCR may not be reliable when determining infectivity/active virus vs the mere presence of viral DNA and therefore while levels detected by rt-PCR do tend to correlate with the active viral load, robust data are lacking to support the utilization of a testing protocol for viral load and decision making in SARS-CoV-2 positive patients. The test may be performed a second time if clinical suspicion or institutional policy warrants repeat testing for the presence of SARS-CoV-2 prior to high-risk procedures.

When determining the appropriate time of tracheostomy in the SARS-CoV-2 patient, several factors are considered, and individual cases may certainly have mitigating circumstances that lead to the decision to perform tracheostomy. However, for the majority of patients, health care teams should seek to capitalize on the intersection of the risk of contamination/infection and decreasing viral load in the upper and lower airways over time with the risks of prolonged intubation (ie, tracheal stenosis, weaning issues, pulmonary toilet, etc.). Although the overall risk of tracheal stenosis secondary to prolonged intubation depends on a variety of factors, reported rates of severe, symptomatic stenosis are generally in the 1% to 2% range when modern low-pressure cuffs are utilized. [28] [29] [30] [31] [32] Therefore, in light of the relatively low risk of clinically relevant stenosis, and despite the traditional 10-day cutoff for increased stenosis risk used by many practitioners in the general population, when dealing with a SARS-CoV-2 patient, the risk for symptomatic or severe tracheal stenosis is acceptable in light of the significant risks of tracheostomy in the acute phase of the infection during periods of the highest viral loads. The decreasing viral load, although logarithmic in nature, is somewhat variable, and high viral loads have been observed somewhat late in the course of the infection in critically ill patients (Figures 1 and 2) . 23, 24, 33 Therefore, when feasible, waiting until approximately 21 days after the onset of symptoms is recommended prior to consideration of tracheostomy for the majority of cases in order to avoid exposing health care teams to increased risk. Earlier tracheostomy may certainly be medically indicated in some situations depending on the clinical situation, or health care system issues during a pandemic situation, and we recognize the potential need to perform tracheostomy more urgently. Tracheostomy should not be delayed regardless of SARS-CoV-2 status in life-saving situations or in situations in which the tracheostomy would significantly improve the prognosis of the patient. Certainly the timing of tracheostomy remains a controversial issue and data is limited related to SARS-CoV-2. 53 Alternative emerging strategies in the management of SARS-CoV-2 critically ill patients, such as extracorporeal membrane oxygenation, antiviral therapy and convalescent plasma therapy, may also be considered by the team, but the available data and decision making regarding this is beyond the scope of these recommendations. [34] [35] [36] [37] [38] Clearly, these are multidisciplinary decisions that will be individualized depending on the patient and institutional expertise.

In addition, it should be noted that avoiding tracheostomy in patients at high risk of mortality is critical. If the primary team managing the patient determines that there is an extremely high risk of mortality in the near future or that the patient has a high likelihood of withdrawal of care, the risks of tracheostomy should be avoided in this situation. Patients with significant medical comorbidities, acute respiratory distress syndrome/severe respiratory failure and a low chance of recovery who are infected with SARS-CoV-2 should be carefully evaluated, and discussions with family members, consultants, institutional ethics committees and the treating team should focus on overall prognosis and goals of care prior to performing tracheostomy as a routine matter of care. These decisions are highly individualized and rely on solid communication among team members managing these highrisk patients. 

Although the exact technical details regarding tracheostomy will depend on the situation and procedural protocols and technical expertise, there are some specific technical aspects related to the SARS-CoV-2 (and other viral pandemics) that should be considered. Ideally, the procedure should be performed at bedside in the intensive care unit in a negative pressure room or using a portable high efficiency particulate air (HEPA) filtration system to avoid patient transportation and contamination of other areas in the medical center. If it is necessary to perform the procedure in the operating room (OR), a specific OR cluster should be designated to avoid contamination of additional OR resources for noninfected patients. In addition to standard airborne and droplet precautions, techniques to minimize aerosolization of the virus during the procedure include the following: paralysis to prevent coughing; consider glycopyrrolate to reduce secretions; preoxygenation and cessation of ventilation during the tracheostomy procedure; utilization of closed suctioning systems; avoiding monopolar electrocautery, or harmonic technology, and using cold instrumentation when feasible; minimizing suctioning and bronchoscopy during the procedure; and ensuring the cuff is inflated prior to resuming ventilation, so the circuit is closed.

In addition to standard open tracheostomy with an apneic technique, percutaneous/dilational tracheostomy techniques have been evaluated extensively in the literature and have been shown to be a safe alternative to traditional open surgical tracheostomy. [39] [40] [41] Understandably, the techniques utilized when performing tracheostomy will vary based on patient characteristics, provider expertise and institutional experience. Although data are limited, techniques that avoid opening the airway and are closed, such as a percutaneous dilational technique, may be preferential in the setting of active SARS-CoV-2 infection. 42, 43 Therefore, if there are no anatomical or other contraindications, percutaneous dilational tracheostomy may be considered if the expertise is available. It should be remembered that the decrease in aerosolization during percutaneous tracheostomy only holds true if airway manipulation (ie, bronchoscopy with cuff deflation or concurrent ventilation) is not performed, and although there have been some associated higher complication rates with blind percutaneous tracheostomy compared to bronchoscopic technique, ultrasound-guided techniques have been shown to be noninferior to bronchoscopic techniques. [44] [45] [46] Therefore, when considering a percutaneous tracheostomy, a closed ultrasound-guided or "cuff-up" apneic technique is recommended for SARS-CoV-2 patients.

Although there are limited data on the current pandemic to fully inform personal protective equipment (PPE) recommendations, performing tracheostomy in an actively infected SARS-CoV-2 patient is certainly a high-risk procedure for health care workers. 47 Health care personnel performing the tracheostomy should wear at minimum: waterproof cap, goggles with an antimist screen, impermeable operating room surgeon's gown and gloves and a transparent plastic facial shield worn outside the goggles and N95 that is effective in filtering 99.5% particles larger than 0.75 μm and 95% effective in the .1 to .3 μm range. 48 The minimum number of health care workers required to perform the procedure should be present to prevent unnecessary exposures.

The effectiveness of the N95 mask in the prevention of SARS-CoV-2 infection during tracheostomy procedures remains unknown, but given the high risk and the reported size of thevirus ranging from 70-90 nm, consideration for power air-purifying respirator (PAPR) systems for personnel performing tracheostomy should be entertained. 54 These systems should be used when available in situations of acute active infection, or suspicion of high viral loads, as there is some evidence of superior protection (PAPR provides 2.5-100 times greater protection than the N95 when staff are appropriately trained). 47, 49, 50 The effectiveness of N95 and PAPR in this situation has certainly not been compared in a head-tohead trial, and therefore, the use of PAPR vs N95 will depend on institutional resources and policy and the clinical situation until further data is available.

Techniques to manage the acute airway with endotracheal intubation, video laryngoscope for example, should be utilized if possible to avoid emergent tracheostomy in SARS-CoV-2 patients due to the high risk of unsafe conditions and health care worker contaminations. 48 Similarly, intubation techniques (ie, rapid sequence intubation) that avoid mask ventilation, such as prolonged open airway manipulation, are recommended when appropriate. When life-threatening airway obstruction occurs in a setting in which intubation is not possible, health care workers should perform the tracheostomy with the above-noted PPE, keeping in mind that PAPR respirator use is often not feasible or available in emergent situations. In situations in which cardiopulmonary resuscitation is being performed, chest compressions should be avoided at the time the airway is entered until the airway is secured and the cuff is inflated on the device to minimize health care worker exposure.

Posttracheostomy management should also be mentioned as, in addition to routine tracheostomy care, there are some considerations for SARS-CoV-2 patients. Securing circuits properly and avoiding unnecessary humidification systems may reduce the risk of unexpected circuit disconnection and aerosolization leading to exposure. The circuit should remain closed as much as possible, and closed-line suctioning should be used. Heat moister exchangers with viral filters and HEPA filtration should be used when possible. Tracheostomy tube changes should be avoided and should only be performed in cases of cuff failure or emergent situations.

Although the members of the health care team performing tracheostomy vary across institutions, team members may include surgeons, medicine/intensivists, anesthesiologists, respiratory therapists, nurses and other ancillary staff required during these procedures. The importance of appropriate PPE/PAPR training and usage cannot be overstated in the setting of active SARS-CoV-2 infection. Teams that perform the procedure regularly will be more efficient and less likely to be unfamiliar with the procedure or appropriate health care protective measures and infection control. The inclusion of trainees such as residents and fellows during these procedures requires careful consideration and will vary based on institutional policies.

Currently, there are limited data on the host innate immune status of SARS-CoV-2 infected patients. 51 Consideration of the inclusion of health care workers who have previously been exposed and subsequently recovered from documented SARS-CoV-2 infection may be warranted. Although the exact timing of immunity and subsequent safety for the return of health care providers infected with SARS-CoV-2 remains unknown, sufficient antibody responses have been documented to occur between 15 and 20 days, or approximately 2 weeks, after the onset of symptoms ( Figure 3 ). 23 Inclusion of these individuals on these teams may allow for high-risk procedures to be performed by health care workers who have mounted an immune response to the virus depending on institutional quarantine policies. Similarly, these individuals should not be involved in tracheostomy procedures or other airway procedures in noninfected patients due to the risk of iatrogenic infection with SARS-CoV-2 due to limited available data about the risks. 52 

Tracheostomy in the SARS-CoV-2 infected patient represents a unique situation, with a unique set of risks and implications. When compared to traditional tracheostomy procedures in the setting of prolonged ventilation, SARS-CoV-2 represents a unique entity in terms of timing, indications and infection control considerations that must be remembered when performing these procedures and managing patient's posttracheostomy. Additional resources are listed below.

• Careful consideration of "who" and "when" when tracheostomy is planned is recommended. • Careful consideration of the location and technique to avoid unnecessary risks to health care providers is recommended. • When clinically appropriate, delay of tracheostomy procedures is recommended to allow for reduced viral load and to decrease the risk of nosocomial infection to critical health care providers. • Selecting appropriately sized endotracheal tube (ETT), and careful monitoring of ETT cuff pressures to maintain appropriate seal to avoid aerosolization when mitigating the risk of long-term tracheal complications is recommended. 

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