Global health care is experiencing an unprecedented surge in the number of critically ill patients who require mechanical ventilation due to the COVID-19 pandemic. The requirement for relatively long periods of ventilation in those who survive means that many are considered for tracheostomy to free patients from ventilatory support and maximise scarce resources.
COVID-19 provides unique challenges for tracheostomy care: health-care workers need to safely undertake tracheostomy procedures and manage patients afterwards, minimising risks of nosocomial transmission and compromises in the quality of care. Conflicting recommendations exist about case selection, the timing and performance of tracheostomy, and the subsequent management of patients.
In response, we convened an international working group of individuals with relevant expertise in tracheostomy. We did a literature and internet search for reports of research pertaining to tracheostomy during the COVID-19 pandemic, supplemented by sources comprising statements and guidance on tracheostomy care. By synthesising early experiences from countries that have managed a surge in patient numbers, emerging virological data, and international, multidisciplinary expert opinion, we aim to provide consensus guidelines and recommendations on the conduct and management of tracheostomy during the COVID-19 pandemic.
The COVID-19 pandemic has led to an unprecedented increase in the number of patients who are critically ill and require mechanical ventilation. Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is associated with lower mortality than the related viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome, it has higher infectivity and rates of transmission.SARS-CoV-2 has spread far more widely and rapidly than these other viruses, resulting in catastrophic loss of life globally.
Hospitals are overwhelmed, and medical professionals must make difficult decisions regarding the care of patients who are critically ill. Tracheostomy is a common procedure in critically ill patients who require an extended period of time on mechanical ventilation. Use of tracheostomy can facilitate weaning from ventilation and potentially increase the availability of intensive care unit (ICU) beds.
When the COVID-19 pandemic spread to Italy and Spain, ICUs had a massive influx of patients who were critically ill, many of whom became candidates for tracheostomy. However, tracheostomy is an aerosolgenerating procedure, so health-care workers are at risk of infection during insertion and subsequent care, even when appropriate personal protective equipment (PPE) is used.
Aerosol-generating procedures were identified as a leading cause of viral transmission during the SARS outbreak in 2003, with super-spreading events occurring throughout hospitals in Hong Kong, China, and Canada. Reports of infections related to aerosol-generating procedures have also emerged in the current pandemic. Although global community-based strategies to manage the impact of COVID-19 are a priority for the general population, tracheostomy is one of a number of important clinical considerations for the optimal management of patients who are critically ill during the pandemic.
We aim to provide authoritative guidance for health-care providers and health-care systems, highlighting the range of considerations for tracheostomy during the current COVID-19 pandemic, by synthesising experience, currently available evidence, and lessons from history. Owing to the urgent need for guidance and the lack of robust ICU outcome data, we make pragmatic recommendations and suggestions primarily on the basis of international, multidisciplinary expert opinion.
COVID-19 in the context of previous epidemics
In response to the threat of Avian influenza, caused by the influenza A H5N1 virus, in 2005, a great deal of pandemic preparedness planning began, with a view not only to treating patients, but also to mitigating the spread of a lethal and easily transmitted respiratory infection. Some of these methods would only be required in worst-case scenarios, such as that seen during the influenza pandemic of 1918–19, because they are socially and economically disruptive.
The hypothesis behind community mitigation has now become popularly known as “flattening the curve”. By delaying the peak of the epidemic, less strain is put on health-care capacity, and the burden on hospitals and infrastructure is reduced. In turn, the overall case numbers and health impacts might be reduced, allowing more time for the development of better medical therapies and preventive vaccines.
An evaluation of these strategies in the context of the 1918–19 influenza pandemic indicated that cities that acted early had much lower morbidity and mortality than those that did not. As we apply these community mitigation strategies on a global level that has never been seen before in human history, future evaluation will determine their effect on the impact of the COVID-19 pandemic. Tracheostomy was an essential clinical strategy for managing epidemics associated with respiratory failure during the 20th century, including those of poliomyelitis and diptheria,and we hope that the careful conduct and management of tracheostomy during the current pandemic will help to reduce the impact of COVID-19.
Patient selection for tracheostomy
First we considered the role of tracheostomy in critical illness and respiratory failure. Approximately 8–13% of patients admitted to modern ICUs who require mechanical ventilation have a tracheostomy. The major indication for tracheostomy remains the facilitation of mechanical ventilation for a long period, while minimising complications from a translaryngeal endotracheal tube and weaning from ventilation.
Tracheostomy might also be required for actual or threatened airway obstruction, laryngeal oedema (which might be an emerging feature of COVID-19) or unsuccessful extubation due to weakness, poor cough, tenacious secretions, or a combination of these factors. Decision making around access to critical care and tracheostomy during the COVID-19 pandemic is based mainly on existing standards of practice, although the evidence base for tracheostomy timing in those who are critically ill is not substantial.
Tracheostomy in the context of critical illness is not always in the patient’s best interests. Among patients without COVID-19 who require tracheostomy after an extended period of mechanical ventilation, at least half do not survive for more than 1 year, and at 1 year fewer than 12% are at home and functionally independent.Similarly, tracheostomy for patients with COVID-19 might not always be beneficial, and the procedure and subsequent care puts health-care workers at increased risk of SARS-CoV-2 infection.
Patients and surrogates need information and discussion in the context of a multidisciplinary team about trade-offs, challenges, and the outcomes of tracheostomy; that tracheostomy in this context will often be followed by long periods of functional dependency and rehabilitation should be explained. These decisions might become more important in an overwhelmed health-care system with few resources to care for patients who are critically ill, recovering, or highly dependent.
Although rationing in health care is not unprecedented, in the modern age we have never before been faced with the prospect of having to ration medical goods and services on such a large scale. Decision makers might have to consider the appropriateness of embarking on a tracheostomy, with the associated health-care resources, in the context of shortages of staff, equipment, medications, and facilities. An independent triage or ethics committee could help to guide decisions, communicate with patients and their relatives, and reduce the burden on frontline staff.
Timing of tracheostomy
Emerging virological data
A systematic review comparing health-care workers who did an aerosol-generating procedure with those who did not during the 2003 SARS outbreak found an increased risk of contracting SARS in those who did a tracheal intubation (odds ratio 6·6 [95% CI 2·3–18·9]) and tracheostomy , and those who put patients on non-invasive ventilation and manual ventilation before intubation .Although data on SARS-CoV-2 infectivity are scarce, infection and death among health-care workers have been reported.3,12 The median time from SARS-CoV-2 exposure to onset of symptoms (incubation period) is approximately 5 days (range 4–14).13,14 SARS-CoV-2 is normally most abundant around the time of symptom onset, as determined by PCR of viral RNA from mucosal samples from the upper respiratory tract.
After symptom onset, viral load typically decreases over the following 3–4 days.15 In most patients, samples from the lower respiratory tract remained PCRpositive for SARS-CoV-2 after samples from the upper respiratory tract had become negative, for up to 39 days.In patients with severe disease, the viral RNA load is significantly higher and decreases more slowly than in those with mild disease. The immune response (antiviral antibody) typically appears both in the respiratory secretions and in the blood around 7 days after symptom onset, and is detectable in 90% of patients by 12 days after symptom onset.
The presence of antibody inhibits the infectivity of detectable virus. The presence of viral RNA detected by PCR (so-called viral shedding), does not necessarily indicate infectivity, especially in the presence of antiviral antibodies.
True infectivity can only be assessed by viral culture in cells in vitro, or be inferred from clinical or epidemiological data. Detailed analysis of nine individuals who developed COVID-19 established virus replication culture at several anatomical sites.19 Pharyngeal viral RNA peaked during the first week of symptoms, reaching 7×10⁸ copies per throat swab on day 4, persisting beyond the duration of symptoms.
By cell culture, infectious viruses were present in samples from the throat and lungs, but not from stool (despite high viral RNA concentrations in faeces); infectious virus was never detected in blood or urine. Serum antibodies were detected after 7 days in half of cases, and in all individuals by day 14. All individuals had mild disease courses.
The authors of this study predicted little residual risk of infectivity beyond 10 days after symptom onset, when the patient had less than 100 000 viral RNA copies per mL of sputum. A timeline of the typical clinical course of severe SARS-CoV-2 infection is shown in figure 1, based on authors’ local data and published case series.13,17,19–23 Further studies are required to define the immune response to SARS-CoV-2 in critically ill patients and in those with comorbidities and those who are immunocompromised, and to establish the viral burden that various aerosolgenerating procedures generate in these patients.
Tracheostomy during the COVID-19 pandemic
Outside the context of the COVID-19 pandemic, controversy exists about the timing of tracheostomy. Although several guidelines support early tracheostomy in select groups of patients, such as those with traumatic brain injury and patients with trauma-related injuries in general, most tracheostomies are done on a case-by-case basis.
Although delaying tracheostomy for patients with COVID-19 might reduce risks for staff, extended duration of translaryngeal intubation, sedation, mechanical ventilation, and ICU stay associated with such delays can lead to complications. We suggest that decision making during the COVID-19 pandemic reflect the range of applicable considerations (figure 2; appendix pp 2–7).
Patient selection for attempted primary extubation should be based on established practice—ie, in those with improving cardiovascular and respiratory physiological parameters, reducing markers of infection and inflammation, and a successful spontaneous breathing trial. However, premature extubation exposes patients and staff to the risks associated with urgent rescue oxygenation strategies and re-intubation. We recommend a conservative approach to attempted extubation, limited to those predicted to have a high chance of success.
Considerations for tracheostomy during the COVID-19 pandemic should continue to emphasise current best practice. When elective tracheostomy is done, an inflated tracheostomy tube cuff via which pressure support ventilation can be delivered affords a closed system for controlled weaning of respiratory support. Although tracheostomy is associated with risks of infectious transmission, a primary extubation strategy in patients for whom the likelihood of success is low also carries risk.
Several members of the consensus working group have personally been involved with or are aware of challenging re-intubations in patients with COVID-19, which suggests a role for mitigating risks of urgent or emergency re-intubation in difficult circumstances. Data are needed to understand attendant risks of infectious exposure to staff and other patients.
Therapies for unsuccessful extubation, such as high-flow oxygenation, continuous positive airway pressure, or non-invasive ventilation, generate hazardous aerosols to varying degrees and might not be appropriate; they also impose a strain on the capacity of hospital wards to deliver oxygen. Recovering patients who continue to require ventilatory support via a tracheostomy can be managed with minimal sedation, which might simplify care and facilitate transfer to lower-acuity facilities, thus creating capacity for more acute patients.
Performance of tracheostomy
Optimal setting for tracheostomy insertion
A variety of logistical and practical considerations influence the optimal location for a tracheostomy procedure in patients who are critically ill, including operator training and expertise; hospital infrastructure, including provision of side rooms and negative pressure air flows; availability of staff and equipment; and the ability to transfer a patient who is critically ill to another setting. Tracheostomy can be done in the ICU (often with suboptimal equipment and lighting, restricted availability of assistants, and suboptimal positioning on wide ICU beds) or in the operating room (requiring transfer from the ICU, exposure risks to multiple staff, and associated logistics).
Percutaneous, surgical, or hybrid approaches can be used in either location. Because tracheostomy is an aerosol-generating procedure,2 we recommend a hierarchical approach to choosing the operative location to balance patient and staff risks (appendix p 1),32 recognising that many health-care facilities lack negative-pressure rooms. Portable highefficiency particulate air filtration systems might be an acceptable alternative.
We suggest that ICU and surgical teams review the optimal location for tracheostomy insertion during the pandemic, balancing the risks to patients and staff and appraising local facilities and expertise. Optimal tracheostomy procedure Health-care workers who do tracheostomies must take into account additional considerations associated with the infectivity of SARS-CoV-2. Of the published cases of tracheostomies done in Singapore, Hong Kong, and Canada during the SARS outbreak, hospitals used enhanced PPE measures in addition to standard PPE, ranging from face shields to powered air-purifyingrespirators (PAPRs) On the basis of these reports, we suggest the use of enhanced PPE, with PAPRs, eye protection, fluid-repellent disposable surgical gown, and gloves.
Optimal management after tracheostomy
Care of patients with COVID-19 after tracheostomy extends from the same fundamental principles of tracheostomy care in all patients. Safe and high-quality care can be provided in various settings.39,40 However, because of the risk of viral transmission, the concept of patient-centred care must be balanced against the safety of health-care workers. Patients need to be managed by experienced staff who are trained in tracheostomy care and management.
Key principles include a focus on essential care and avoidance of unnecessary interventions (especially those that generate aerosols), early recognition of deterioration, and timely response to emergencies. Airway interventions should be planned in advance, as far as possible, to allow appropriate PPE to be applied. The use of PPE by staff remains a priority even in emergencies, and we suggest preparing systems to summon help from adjacent areas where staff might already be wearing PPE.
Standard approaches to managing tracheostomy emergencies should be followed. Patients with existing tracheostomies who do not have COVID-19 are at unknown risk of SARS-CoV-2 infection from visitors and staff. Safe locations need to be identified to manage patients with COVID-19 and those without COVID-19 with differing care needs, and consideration of novel options beyond standard hospital ward settings might be necessary, such as maximising use of telemedicine where applicable.
Author: Michael J Brenner,Stephen J Warrillow