The Royal College of surgeons multidisciplinary guidelines on elective tracheostomy insertion in COVID-19 ventilated patients



# Ventilated patients introduction
The global pandemic of Coronavirus disease 2019 (COVID-is caused by a new strain of Coronavirus (SARS-CoV-2) discovered in 2019 and not previously identified in humans. The worldwide impact of the disease -33.7 million cases in 213 countries -indicates the highly contagious nature of the virus. Direct person-to-person transmission occurring during close contact mainly via respiratory droplets is the main mode of transmission. Healthcare workers are particularly at risk of contracting COVID-19 due to their exposure to infected patients, their inability to maintain social distancing while working in teams and the limited availability of personal protective equipment (PPE). Acute Respiratory Distress Syndrome (ARDS), a syndrome of hypoxia and loss of lung compliance resulting from alveolar-capillary barrier disruption and an inflammatory pulmonary edema, occurs in 10e17% of patients with COVID-19. [bib_ref] Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in..., Yang [/bib_ref] [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] Approximately 5e10% of hospitalised patients require invasive mechanical ventilation, the majority of whom fulfill criteria for ARDS. [bib_ref] Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak..., Wu [/bib_ref] Data on duration of ventilation indicates a requirement for prolonged advanced respiratory support (median of 13 days, ICNARC report Sept 25th 2020), while a rise in patients requiring invasive mechanical ventilation will lead to an increase in tracheostomies performed. [bib_ref] Duration of quarantine in hospitalized patients with severe acute respiratory syndrome coronavirus-2..., Lombardi [/bib_ref] 

# Discussion
Tracheostomy is a common procedure performed in patients requiring prolonged mechanical ventilation. In this group, tracheostomy improves patient comfort, reduces trauma to the larynx, leads to a reduced need for sedation and improves patient communication. Prolonged translaryngeal intubation increases the risk of tracheal stenosis over time. Adequate endotracheal cuff pressures are required to minimise aerosolisation in ventilated patients, with care taken to avoid unnecessarily high pressures leading to tracheal pressure injury. [bib_ref] Classification of laryngeal injury in patients with prolonged intubation and to determine..., Mehel [/bib_ref] Prior to the onset of the SARS-CoV-2 pandemic, there was no agreed optimal timing of tracheostomy tube insertion to facilitate weaning from mechanical ventilation. [bib_ref] Hospital variation in early tracheostomy in the United States: a population-based study, Mehta [/bib_ref] The landmark TracMan trial found no advantage of early (<4 days) tracheostomy in relation to 30-day mortality, duration of mechanical ventilation, or length of time in critical care. [bib_ref] Effect of early vs late tracheostomy placement on survival in patients receiving..., Young [/bib_ref] In addition, over half of the subjects randomised to the late tracheostomy arm did not receive the intervention. This suggests that postponing tracheostomy beyond 4 days allows a subset of patients to avoid the intervention. Thus, there is no clear benefit to early tracheostomy for mechanically ventilated patients in the ICU. However, a lower incidence of pneumonia with early tracheostomy was suggested by a recent meta-analysis. [bib_ref] Effect of early versus late or no tracheostomy on mortality and pneumonia..., Siempos [/bib_ref] Tracheostomy decreases sedation requirements, avoids pressure induced trauma (both to the trachea and oral cavity), and may reduce the severe physical deconditioning associated with prolonged mechanical ventilation. [bib_ref] Impact of tracheotomy on sedative administration, sedation level, and comfort of mechanically..., Nieszkowska [/bib_ref] COVID-19 complicates matters further in terms of timing and choice of technique, with important considerations of risk to staff as well as patients. The viral load of patients infected with SARS-CoV2 decreases over time leading to a reduction in the risk of transmission during tracheostomy. [bib_ref] Quantitative detection and viral load analysis of SARS-CoV-2 in infected patients, Yu [/bib_ref] [bib_ref] SARS-CoV-2 viral load in upper respiratory specimens of infected patients, Zou [/bib_ref] As such, the later timing of tracheostomy during the COVID-19 pandemic may be a justifiable consideration in the current circumstances. Delaying tracheostomy insertion in these patients until 14 or even 21 days of ventilation if feasible has been recommended. [bib_ref] Safety recommendations for evaluation and Surgery of the Head and Neck during..., Givi [/bib_ref] [bib_ref] Tracheostomy during SARS-CoV-2 pandemic: recommendations from the New York Head and Neck..., Miles [/bib_ref] Both open and percutaneous methods for tracheostomy tube insertion can be used in patients with COVID-19. Although data are limited, the percutaneous dilational method may lead to less risk of procedural transmission of SARS-CoV2 given that it does not involve opening the airway. [bib_ref] Open tracheostomy in a suspect severe acute respiratory syndrome (SARS) patient: brief..., Ahmed [/bib_ref] [bib_ref] Bedside percutaneous tracheostomy in acquired immunodeficiency syndrome, Flum [/bib_ref] This method must be used without airway manipulation such as bronchoscopy with cuff deflation to have benefit over open techniques. If the patient's anatomy is favourable and there are no contraindications to percutaneous tube insertion, then this method may be preferred in patients with COVID-19 infection. The mortality rate for patients requiring ICU admission with confirmed COVID-19 is high at 51.6%.Therefore, the selection of patients for tracheostomy insertion requires careful consideration. Patients should be haemodynamically stable with low vasopressor requirements. They should not require a PEEP >8cmH 2 O, FiO2 >0.5 or a pressure support >12cmH 2 O. Patients with tracheostomy can be nursed in the prone position but the airway cannot be visualised, risking displacement and pressure damage, therefore tracheostomy is not recommended in those still requiring prone ventilation. The decision to perform tracheostomy should be deferred in patients who are deemed to have a low chance of recovery or a high chance of mortality in the near future. These decisions should be made on a caseby-case basis by senior team members.
The upper aerodigestive tract, trachea and nasopharynx contain a high viral load during the early stages of infection with [bib_ref] Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum..., To [/bib_ref] In patients with severe infection the viral RNA load is significantly higher and decreases more slowly than those with mild infection. [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] Any airway procedure, including endotracheal intubation and tracheostomy, markedly increases the risk of exposure and transmission from patient to healthcare worker. [bib_ref] Transmission of severe acute respiratory syndrome during intubation and mechanical ventilation, Fowler [/bib_ref] Aerosol-generating procedures should be avoided where possible during this time. Infection control to limit the transmission of COVID-19 is an integral part of the care of patients with suspected or confirmed infection. For patients with suspected or confirmed COVID-19 infection, who undergo aerosol-generating procedures, PPE requirements for healthcare workers include a gown, eye protection, gloves, shoe covers and a suitable respirator offering a high level of protection.Any uncovered skin, hair or shoes worn by the worker is at risk of contamination with aerosols. [bib_ref] Exposure to a surrogate measure of contamination from simulated patients by emergency..., Feldman [/bib_ref] Healthcare workers should undergo training for the donning and doffing of PPE.
During tracheostomy tube insertion, deep neuromuscular blockage should be used to minimise patient movement and coughing. Pausing ventilation and placing the endotracheal tube cuff distal to the tracheostomy insertion point also minimises aerosol generation. Where possible, tracheostomy tube insertion should take place in a neutral pressure suite or Airborne Isolation and Infection Room (AIIRS). The next preferable location is a negative pressure airborne isolation room. This is a single-patient room in which a minimum of six air exchanges per hour takes place at a negative pressure when compared with surrounding areas. An operating theatre with laminar air flow stopped and doors sealed during and after the procedure for 30 min is also an acceptable option. A cuffed non-fenestrated tube should be used with the cuff adequately inflated to minimise aerosol risks to staff.
Tracheostomy management in patients with COVID-19 should be modified. A number of recommendations have been made to minimise aerosol generation during the care of these patients. Early management should include keeping the cuff inflated, closed-suction system, an in-line viral filter and avoidance of nebulisation. These measures should be put in place until the is considered non-infectious. Tracheostomy tube changes and decannulation protocols can then be considered. [bib_ref] Recommendation of a practical guideline for safe tracheostomy during the COVID-19 pandemic, Takhar [/bib_ref] Protocols should be established for patients discharged to ward level from ICU for management of tracheostomy not connected to a closed ventilatory circuit. Simple heat moisture exchanger (HME) devices may act as droplet barriers. In-line suctioning can be attached to the tracheostomy tube prior to the HME. Humidification and nebulisation should be limited. The use of disposable inner cannulas is preferred to avoid brush cleaning of reusable inner cannulas at risk of aerosolisation. [bib_ref] Tracheostomy management during the COVID-19 pandemic, Goldman [/bib_ref] Effective communication between all team members is essential during tracheostomy tube insertion to minimise risk t h e s u r g e o n 1 9 ( 2 0 2 1 ) e 2 6 5 ee 2 of procedural viral transmission. Teams that perform tracheostomy regularly are bound to do so in a more efficient manner. Tracheostomy guidelines from ENT-UK suggest the creation of a "COVID Airway Team" to concentrate experience and coordinate training locally.This improves safety and leads to familiarity with the new infection control measures needed to protect healthcare workers.

## Recommendations
The following are recommendations from our combined departments, in the Royal College of Surgeons in Ireland, based on our expertise managing this emergent public health threat. We acknowledge these recommendations may require individualization based on region, facility, resources, clinical expertise, and patient-specific factors. The major objective of tracheostomy guidelines in the context of a COVID-19 pandemic is to promote safety and encourage excellent communication between Intensive Care Medicine/Anaesthesia, Respiratory, Surgical, and Nursing staff.

## A multidisciplinary team composing of consultant
Surgical and Intensive Care Medicine/Anaesthesia physicians should review all cases considering the risk versus benefit for the patients, operating clinician and the entire healthcare team. Communication and collegial support is essential. 2. Patient selection is very important. Anatomy, history, comorbidities, clinical course (current and projected) may result in increased complications and procedures being postponed or indeed cancelled. 3. In the context of this COVID-19 pandemic most tracheostomy procedures should be avoided or delayed until 14 days after symptom onset because of the high risk of viral aerosolization during the acute phase of the infection. The anticipated timing for viral clearance cannot be predicted currently. Furthermore, critically ill patients demonstrate longer periods of viral shedding. [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] The higher the viral load during the acute phase of the illness, the higher the aerosolization risk. An Evidence Summary for COVID-19 viral load over course of infection compiled by the Health Information and Quality Authority in Ireland reports that viral loads are highest at the time of symptom onset and remain high for the first few days followed by a decrease over the next 1e3 weeks (15 studies) The median duration of virus detection based upon RT PCR is 13 days (16 studies). 29 4. The patient considered for tracheostomy should be haemodynamically stable (minimal vasopressor requirement) and not require prone ventilation, high levels of Positive End Expiratory Pressure (PEEP) (>8cmH2O), Fraction of inspired oxygen (FiO 2 ) (>0.5), or pressure support (>12cmH 2 O). 5. Avoid tracheotomy in COVID-19 positive or suspected patients (at any time) during periods of respiratory instability or heightened ventilator dependence. 6. We acknowledge that resource constraints during a surge in Intensive Care Unit demand may necessitate tracheostomy formation to facilitate patient transfer from an ICU to a COVID High Dependency Unit (HDU) or stepdown facility, thereby freeing the ICU for patients deemed in greater immediate clinical need. 7. The optimal location for tracheostomy placement in order of preference is: a. Neutral pressure suite, comprising a HEPA filtered ante-room (10% atmospheric for donning), all air flowing to the patient care area (5% above atmospheric) air flowing to the Doffing area and sluice (atmospheric pressure). b. Negative pressure Room. c. Theatre environment which has had laminar flow system stopped and all doors sealed for the duration and 30 min after the procedure in line with anaesthesia guidelines. 8. Consideration should be given to percutaneous dilatational tracheostomy if the patient's anatomy and proceduralist expertise allow it to be done safely with bronchoscopy performed during pauses at end e Open tracheostomy COVID checklist.
t h e s u r g e o n 1 9 ( 2 0 2 1 ) e 2 6 5 ee 2 6 9 expiation only to minimise aerosolisation, endotracheal suctioning, and disruption of the ventilator circuit. Open procedures generate more aerosolization and should be avoided if possible. 9. Choose a non-fenestrated, cuffed, tracheostomy tube.
Standard size 8 for males and 6 for females. The cuff should remain adequately inflated to limit viral dispersion and transmission through the upper airway during ventilation. 10. When performing the tracheostomy procedure provide adequate sedation and paralysis to eliminate the risk of coughing during the procedure. Ventilation should be paused (apnoea) at end-expiration when the trachea is accessed and any time the ventilation circuit is disconnected. 11. Perform tracheostomy suctioning using a closed suction system, use circuits with viral filters or HMEs which exhibit high viral filtration efficiencies. Use a HME device attached to a non-vented tracheal adaptor or closed suction system instead of a tracheostomy collar during weaning to humidify the inhaled gases and minimize droplet dispersion and aerosolization during coughing and tracheal suctioning. 12. Adhere to strict donning and doffing procedures in full Personal Protective Equipment (PPE) based on institutional protocol. Limit the number of providers participating in tracheotomy procedure and post-procedure management. Rely on cold instrumentation and avoid monopolar electrocautery.
13. Tracheostomy downsizing should be avoided, and decannulation decisions should be clinician led and be commenced at the earliest opportunity.
In the event of a tracheostomy we advise the following checklists for open and percutaneous [fig_ref] Figure 2 e: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J,... [/fig_ref] methods.

# Conclusion
Tracheostomy insertion in patients with COVID-19 presents a set of new challenges and risks. The importance of training and planning during this time cannot be overstated.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

## Declaration of competing interest
[fig] Figure 2 e: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020;382(8):727e33. 2. Phua J, Weng L, Ling L, Egi M, Lim C-M, Divatia JV, et al. Intensive care management of coronavirus disease 2019 Percutaneous tracheostomy COVID checklist. [/fig]