Multidisciplinary guidance for safe tracheostomy care during the COVID19 pandemic: the NHS National Patient Safety Improvement Programme (NatPatSIP)

The COVID-19 pandemic is causing a significant increase in the number of patients requiring relatively prolonged invasive mechanical ventilation and an associated surge in patients who need a tracheostomy to facilitate weaning from respiratory support. In parallel, there has been a global increase in guidance from professional bodies representing staff who care for patients with tracheostomies at different points in their acute hospital journey, rehabilitation and recovery. Of concern are the risks to healthcare staff of infection arising from tracheostomy insertion and caring for patients with a tracheostomy. Hospitals are also facing extraordinary demands on critical care services such that many patients who require a tracheostomy will be managed outside established intensive care or head and neck units and cared for by staff with little tracheostomy experience. These concerns led NHS England and NHS Improvement to expedite the National Patient Safety Improvement Programme's 'Safe Tracheostomy Care' workstream as part of the NHS COVID-19 response. Supporting this workstream, UK stakeholder organisations involved in tracheostomy care were invited to develop consensus guidance based on: expert opinion; the best available published literature; and existing multidisciplinary guidelines. Topics with direct relevance for frontline staff were identified. This consensus guidance includes:

## Summary
The COVID-19 pandemic is causing a significant increase in the number of patients requiring relatively prolonged invasive mechanical ventilation and an associated surge in patients who need a tracheostomy to facilitate weaning from respiratory support. In parallel, there has been a global increase in guidance from professional bodies representing staff who care for patients with tracheostomies at different points in their acute hospital journey, rehabilitation and recovery. Of concern are the risks to healthcare staff of infection arising from tracheostomy insertion and caring for patients with a tracheostomy. Hospitals are also facing extraordinary demands on critical care services such that many patients who require a tracheostomy will be managed outside established intensive care or head and neck units and cared for by staff with little tracheostomy experience. These concerns led NHS England and NHS Improvement to expedite the National Patient Safety Improvement Programme's 'Safe Tracheostomy Care' workstream as part of the NHS COVID-19 response. Supporting this workstream, UK stakeholder organisations involved in tracheostomy care were invited to develop consensus guidance based on: expert opinion; the best available published literature; and existing multidisciplinary guidelines. Topics with direct relevance for frontline staff were identified. This consensus guidance includes:

# Introduction
The coronavirus disease 2019 (COVID-19) pandemic is having a significant impact on the delivery of health and social care in the UK, with a significant surge in the numbers of patients requiring prolonged mechanical ventilation. Our experience mirrors that from China and elsewhere in Europe, and critically ill patients requiring invasive ventilation have up to 50% mortality, with survivors requiring prolonged support [bib_ref] Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in..., Wang [/bib_ref] [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] [bib_ref] Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience..., Grasselli [/bib_ref] [bib_ref] Clinical features of patients infected with 2019 novel coronavirus in Wuhan, Huang [/bib_ref] [bib_ref] Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in..., Yang [/bib_ref] [bib_ref] Epidemiologic features and clinical course of patients infected with sars-cov-2 in Singapore, Young [/bib_ref]. Prolonged trans-laryngeal tracheal intubation and ventilation is associated with respiratory muscle weakness and delayed recovery, together with overt and occult laryngeal dysfunction. These factors led to tracheostomy being performed in 8-13% of all critically ill patients before the COVID-19 pandemic, usually at the bedside in the intensive care unit (ICU) by intensivists, typically using a percutaneous technique [bib_ref] Targeted training using paediatric tracheostomy emergency algorithm improves performance in simulated scenarios, Doherty [/bib_ref] [bib_ref] Trends in tracheostomy for mechanically ventilated patients in the United States, Mehta [/bib_ref]. In-hospital mortality was around 20% for patients who required tracheostomy, though most commonly due to their underlying disease processes, and thereafter about 50% do not survive beyond 1 year [bib_ref] Long-term acute care hospital utilization after critical illness, Kahn [/bib_ref].
There has been an initial reluctance to perform tracheostomy in patients with COVID-19 due to early reports of high mortality and concerns regarding transmission of infection to healthcare workers. Whereas SARS-CoV-2, the virus responsible for COVID-19, has lower case fatality rates than coronaviruses which cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), it has significantly higher infectivity [bib_ref] Surviving Sepsis Campaign: guidelines on the management of critically ill adults with..., Alhazzani [/bib_ref] [bib_ref] Surgical considerations for tracheostomy during the COVID-19 pandemic: lessons learned from the..., Tay [/bib_ref]. The virus is transmitted directly through surface spread from respiratory droplets, with later mucosal contact and via direct respiratory droplet inhalation. Transmission to healthcare staff is also possible during aerosol-generating procedures, which include tracheostomy insertion and subsequent management. There was an increased risk of contracting SARS among healthcare workers involved in: tracheal intubation (OR 6.6); tracheostomy (OR 4.2); noninvasive ventilation (OR 3.1); and manual ventilation before intubation (OR 2.8) [bib_ref] Aerosol generating procedures and risk of transmission of acute respiratory infections to..., Tran [/bib_ref]. Reports of viral transmission have also emerged in the current pandemic [bib_ref] Clinical Characteristics of 54 medical staff with COVID-19: a retrospective study in..., Chu [/bib_ref] [bib_ref] Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong, Hui [/bib_ref] [bib_ref] Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19)..., Wang [/bib_ref].
Emerging data around infectivity, viral and antibody testing, and the volume of patients requiring tracheostomy have fuelled uncertainty and anxiety among the many multidisciplinary staff required to safely manage patients.

# Methods
The working party was convened rapidly by invitation to the known UK stakeholder organisations involved in tracheostomy care. Given the pressing need for cohesive guidance, formal endorsement was not sought from individual organisations, but much of the content was derived from updated or new COVID-19 pandemic specific guidance published and approved by these stakeholders.

## Covid-19 infectivity and the influence on tracheostomy timing
Whereas a detailed review of the characteristics of SARS-CoV-2 are beyond the scope of this document, an understanding of the natural history of the disease is relevant to the timing and conduct of tracheostomy insertion, subsequent management and the protection of staff. The median incubation period from exposure to symptoms is approximately 5 days [bib_ref] Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in..., Wang [/bib_ref] [bib_ref] Clinical characteristics of coronavirus disease 2019 in China, Guan [/bib_ref]. Viral RNA can be detected in upper respiratory tract secretions by polymerase chain reaction (PCR), peaking around the time of symptom onset, and declining over the following 3-4 days in mild illness [bib_ref] SARS-CoV-2 viral load in upper respiratory specimens of infected patients, Zou [/bib_ref].
The body's immune response is to produce specific antiviral antibodies, which appears around 1 week after symptom onset, and these are detectable in 90% of those affected by day 12 [bib_ref] Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Zhao [/bib_ref]. The infectivity of a person relates to their ability to transmit live virus to another and can only be assessed by culture of detected virus. The quantity of virus required to infect another is currently unknown, but the highest risk is associated with respiratory secretions. The detection of viral RNA by PCR (often referred to as 'viral shedding') does not necessarily indicate infectivity, as non-viable virus can be detected. The anatomical source and the performance of the PCR test also influences detection.
In critically ill patients (those more likely to require tracheostomy), viral RNA load has been shown to be significantly higher and decline more slowly [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] [bib_ref] Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Zhao [/bib_ref] [bib_ref] Viral dynamics in mild and severe cases of COVID-19, Liu [/bib_ref]. The typical clinical course of severe COVID-19 can be described based on published case series, corroborated following personal communication with colleagues in China and Europe [fig_ref] Figure 1: Schematic flow of symptomatic COVID-19 patients admitted to UK hospitals [/fig_ref] [bib_ref] Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in..., Wang [/bib_ref] [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] [bib_ref] Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience..., Grasselli [/bib_ref] [bib_ref] Clinical features of patients infected with 2019 novel coronavirus in Wuhan, Huang [/bib_ref] [bib_ref] Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in..., Yang [/bib_ref] [bib_ref] Epidemiologic features and clinical course of patients infected with sars-cov-2 in Singapore, Young [/bib_ref]. Whereas geographical variation occurs, 6-12% of symptomatic cases with detectable virus require critical care admission and up to 70-80% of these patients require invasive ventilation. Of those requiring invasive ventilation, 40-60% will not survive [bib_ref] Intensive care management of coronavirus disease 2019 (COVID-19): challenges and recommendations, Phua [/bib_ref]. Emerging UK data are skewed towards shorter intensive care lengths of stay, but around 10% of patients admitted to intensive care can be expected to require ventilation beyond 14 days [bib_ref] Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in..., Wang [/bib_ref] [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] [bib_ref] Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience..., Grasselli [/bib_ref] [bib_ref] Clinical features of patients infected with 2019 novel coronavirus in Wuhan, Huang [/bib_ref] [bib_ref] Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in..., Yang [/bib_ref] [bib_ref] Epidemiologic features and clinical course of patients infected with sars-cov-2 in Singapore, Young [/bib_ref]. By pooling data from two studies of 181 patients [bib_ref] Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Zhao [/bib_ref] [bib_ref] Virological assessment of hospitalized patients with COVID-2019, W Olfel [/bib_ref] , which included 32 (17.7%) 'critical' and 72 (40%) 'severe' cases (based on overlapping case series [bib_ref] Clinical course and risk factors for mortality of adult inpatients with COVID-19..., Zhou [/bib_ref] , the viral profile can be characterised [fig_ref] Figure 2: Stylised viral profile from pooled data from two studies of 181 patients [/fig_ref]. Whereas the true level of infectivity is unknown, it is likely to be low around the time that tracheostomy is considered, some 10-14 days [bib_ref] Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Zhao [/bib_ref] [bib_ref] Virological assessment of hospitalized patients with COVID-2019, W Olfel [/bib_ref]. The curves show; the proportion of patients with detectable SARS COV-2 RNA on polymerase chain reaction (diamonds); antiviral antibody (triangles); and inferred infectivity (high to low). Timeline (not to scale) highlights initial exposure followed by typical symptom onset, hospital admission, ICU admission, and the tracheostomy window. Tracheostomy is considered 10-14 days after ICU admission, or approximately 20-24 days after the onset of symptoms.
The COVID-19 pandemic notwithstanding, optimal timing of tracheostomy in the critically ill is unclear [bib_ref] Tracheostomy tube occlusion protocol predicts significant tracheal obstruction to air flow in..., Rumbak [/bib_ref] [bib_ref] Effect of early vs late tracheostomy placement on survival in patients receiving..., Young [/bib_ref] [bib_ref] Timing of tracheostomy in critically ill patients: a meta-analysis, Huang [/bib_ref] [bib_ref] Early versus late tracheostomy for critically ill patients, Andriolo [/bib_ref] [bib_ref] Effect of early versus late or no tracheostomy on mortality and pneumonia..., Siempos [/bib_ref].
Delaying tracheostomy for patients harbouring SARS-CoV-2 may reduce infection risks for staff, but these risks must be They also impose a strain on ward-level hospital oxygen delivery capacity [bib_ref] Consensus guidelines for managing the airway in patients with COVID-19, Cook [/bib_ref]. A conservative approach to attempted primary tracheal extubation is recommended, restricted to those predicted to have a high chance of success. Elective tracheostomy offers a 'closed' system for controlled weaning of respiratory support which may be preferable to a high-risk primary tracheal extubation strategy. Patients continuing to receive ventilatory support via a tracheostomy can be managed with reduced or no sedation, which may ease logistical work-loads, reduce the requirement for specialist critical care nursing, and facilitate transfer to lower acuity care areas to maintain intensive care capacity.
Anecdotal reports are emerging of significant laryngeal oedema and laryngeal ulceration in patients with COVID-19 [bib_ref] Laryngeal oedema associated with COVID-19 complicating airway management, Mcgrath [/bib_ref]. Whereas post-intubation laryngeal oedema is not uncommon in the critically ill, coronaviruses are known to cause laryngitis and it is plausible that SARS-CoV-2 has additional direct laryngeal effects in some people [bib_ref] Laryngeal injury and upper airway symptoms after oral endotracheal intubation with mechanical..., Brodsky [/bib_ref] [bib_ref] What we know so far: COVID-19 current clinical knowledge and research 2020, Lake [/bib_ref]. A pre-extubation tracheal tube cuff deflation 'leak test' should be considered as a screening surrogate of upper airway patency, with laryngoscopy indicated if there is doubt.
Tracheostomy may be indicated if airway oedema does not improve over time, especially when the larynx appears significantly oedematous at laryngoscopy [bib_ref] Cuff-leak test for predicting postextubation airway complications: a systematic review, Zhou [/bib_ref]. The role of steroids in treating airway oedema in the setting of COVID-19 is uncertain.

## Tracheostomy-associated aerosol generation
Droplet transmission of SARS-CoV-2 occurs via large respiratory droplets, which are subject to gravity and typically travel less than 1 metre in air [bib_ref] Personal protective equipment during the COVID-19 pandemic -a narrative review, Cook [/bib_ref]. Airborne tracheal suction; airway endoscopy; bronchoscopy; and mask ventilation [bib_ref] Aerosol generating procedures and risk of transmission of acute respiratory infections to..., Tran [/bib_ref]. To reduce the risk of transmission via aerosolisation, strategies to reduce coughing, reduce positive pressure delivered to an unsealed airway, and reduce exposure to respiratory droplets are recommended [bib_ref] Consensus guidelines for managing the airway in patients with COVID-19, Cook [/bib_ref]. These recommendations can be reasonably extrapolated to include positive pressure applied to an uncuffed, fenestrated, or cuff-deflated tracheostomy tube.
Interventions that bring staff into proximity of respiratory, oral and aerodigestive tract secretions should also be [bib_ref] Surgical considerations for tracheostomy during the COVID-19 pandemic: lessons learned from the..., Tay [/bib_ref] [bib_ref] Tracheotomy in ventilated patients with COVID-19, Chao [/bib_ref]. Bronchoscopic guidance of the tracheal puncture likely improves the safety of the procedure, but makes aerosol generation even more likely [bib_ref] Surgical tracheostomies in COVID-19 patients: important considerations and the "5Ts" of safety, Broderick [/bib_ref]. The choice of using bronchoscopy during percutaneous tracheostomy in a patient with COVID-19
should reside with the operative team. If used, single-use bronchoscopes with a sealed ventilator circuit are recommended. Whereas ultrasound guidance of the puncture (in addition to pre-procedural ultrasound of the neck to identify vasculature) and para-tracheal tube bronchoscopy have been described to reduce aerosolisation, operators should only undertake procedures with which they are familiar and are competent to perform. Surgical tracheostomies were favoured over percutaneous tracheostomies during the SARS outbreak,
with a controlled open approach thought to have less aerosol potential than a percutaneous approach [bib_ref] Surgical considerations for tracheostomy during the COVID-19 pandemic: lessons learned from the..., Tay [/bib_ref] [bib_ref] Elective and emergency surgery in patients with severe acute respiratory syndrome (SARS), Tien [/bib_ref] [bib_ref] Infection control measures for operative procedures in severe acute respiratory syndromerelated patients, Chee [/bib_ref]. This conclusion is shared by some groups in the current pandemic, although it is noteworthy that percutaneous techniques have since advanced [bib_ref] Tracheotomy in ventilated patients with COVID-19, Chao [/bib_ref]. [bib_ref] Safety recommendations for evaluation and surgery of the head and neck during..., Givi [/bib_ref].
Humidification and removable inner cannulae are routinely used during ventilated and non-ventilated tracheostomy care to prevent tube occlusion from respiratory secretions and reduce the need for suction [bib_ref] Safety recommendations for evaluation and surgery of the head and neck during..., Givi [/bib_ref] [bib_ref] Practical aspects of otolaryngologic clinical services during the 2019 novel coronavirus epidemic, Chan [/bib_ref]. Commencing immediate postoperative care with a simple heat and moisture exchange (HME) filter (which can be changed every 7 days in a 'dry' circuit) combined with inner tube inspection and change every 24 h appears safe [bib_ref] In vitro evaluation of heat and moisture exchangers designed for spontaneously breathing..., Brusasco [/bib_ref]. However, experience from other countries suggests that secretions may become thicker over time and active, water-based humidification may become necessary. The role of the respiratory physiotherapist as part of the multidisciplinary team is critical in maintaining chest clearance. Mucolytic drugs may be a useful alternative or adjunct. Saline or hypertonic saline nebulisers can be of benefit, but the addition of humidification or saline significantly reduces HME filter efficiency. The HME filters should be inspected daily and at any time when there is a deterioration in ventilation [bib_ref] Consensus guidelines for managing the airway in patients with COVID-19, Cook [/bib_ref]. Whereas patients are considered infectious, ventilation should be paused following pre-oxygenation before circuit breaks to change inner tubes or HME filters. Staff should be familiar with how to do this on the range of ventilators they are working with. The key elements of the National Tracheostomy Safety Project daily care bundle for adults. Minimum frequency ranges extended for COVID-19 patients, but this must be reviewed daily. Adapted from NHS England and NHS Improvement NatPatSIP.
[fig] Figure 1: Schematic flow of symptomatic COVID-19 patients admitted to UK hospitals. [/fig]
[fig] Figure 2: Stylised viral profile from pooled data from two studies of 181 patients [/fig]
[table] Table 2: Summary of aerosol-generating procedures and recommended personal protective equipment for staff caring for patients with confirmed or suspected COVID-19.Entry into COVID-19 cohort open area, closed bay or single-occupancy room. Care, procedures or assessments delivered with no aerosol generating procedures.Patient wears a surgical facemask and tube covering or trachy-mask during staff contact.Ventilator careChange of ventilator circuit or HME filter.Positive-pressure ventilation or frequent aerosol-generating procedure locations (ICUs, closed bays, single-occupancy room). Cuff down with a ventilator Cuff deflation trials receiving positive-pressure ventilation Patients can be managed on designated tracheostomy wards when they no longer need ventilatory support and their medical and nursing needs become less intensive. Most patients will be suitable for decannulation during their hospital admission, but some will require ongoing care and rehabilitation before decannulation. Community locations should be staffed and equipped to deliver safe care, following the principles described in the NatPatSIP toolkit (Table 1). Clear plans for daily care, PPE requirements, review and decannulation should be communicated to the patient, their family and the community care teams when planning discharge. Multidisciplinary follow-up clinics are recommended [61]. Infection prevention guidance in the UK advises the use of PPE based on risk assessment and the level of SARS-CoV-2 transmission present in the community at the time. With the current high community prevalence, patients admitted to hospital with existing tracheostomies should be tested immediately and isolated if possible until infection is excluded. Patients who are non-infectious should be managed in safe cohort locations, separate from infectious or recovering patients, and standard infection prevention precautions must continue. Appropriate use of PPE is only one part of a system to reduce the risks of contamination and infection to healthcare workers [62]. Extensive advice on infection control related to COVID-19 is published by Public Health England [30, 63]. Minimal PPE includes the use of gloves, aprons, eye protection and a fluid repellent surgical face mask for direct contact. Enhanced PPE is required for aerosol-generating procedures and includes the additional use of a long-sleeved fluid-repellent gown/coveralls and an FFP3 or N95 respirator or PAPR. Eye protection is recommended for all tracheostomy care. Respiratory PPE choice is influenced by the likelihood of aerosol-generation, the requirement for positive-pressure ventilation and whether the patient will be managed with a deflated or uncuffed tube (). Specific considerations for children with tracheostomies and their family/carers are detailed elsewhere (www.tracheostomy.org.uk). For patients receiving positive-pressure ventilation or pressure support, a cuff-inflated system with closed 'in-line' suction will minimise aerosolisation. However, the positive pressure makes aerosolisation from general and tracheostomy care more likely, rendering these environments high-risk. Aerosol generating procedures still occur in non-ventilated patients due to coughing and contact with respiratory or oral secretions. A 'Kelley' circuit allows closed suction to remain connected, with an expiratory viral HME filter in situ [64]. This may be helpful for non-ventilated patients. The requirement for oxygen, humidification and frequency of inner tube care should be reviewed daily. Patients with deflated cuffs should be asked to wear a fluid-resistant surgical mask. As patients recover and become non-infectious, tracheostomy care and PPE use will continue based on risk assessment, returning to infection prevention standard precautions in line with individual patient need. Healthcare professionals should remain cautious until it is clear that this transition has occurred. The recommendations made in this multidisciplinary, multispecialty guidance are based on reports from previous epidemics, early experience of countries affected by the current pandemic and on expert consensus opinion. The effectiveness of these recommendations will only be realised through comprehensive data collection and analysis. The Global Tracheostomy Collaborative (GTC) database (www.globaltrach.org) is freely available for sites to collect comprehensive patient-level data, harm metrics and surrogates for the quality of care, such as time to vocalisation, oral intake and decannulation. Implementation of the GTC Quality Improvement programme has recently demonstrated rapid improvements in the quality and safety of clinical care, using the GTC database to benchmark against the 7000 global cases currently registered in the dataset. Recognising the urgency of data collection, the surgical stakeholders have collaborated to develop a registry of patients undergoing tracheostomy during the pandemic (www.entuk.org; www. laryngology.uk; www.baoms.org.uk). Data about infectivity and the persistence of viral RNA in critically ill patients and the transmission potential of various aerosol-generating procedures are lacking and future research may help to inform optimal timing, performance and management of tracheostomy. The challenge of providing safe, high quality care to high volumes of initially infectious complex patients is upon us. Stakeholders can support, guide and protect staff with measured, collaborative and consistent guidance founded upon best practices and emerging information. [/table]