Tracheostomy in patients with COVID-19-associated respiratory failure is a challenge procedure due both to its severity, duration and risk of infections.
From data emerging in literature and based on clinical experience, patients with COVID-19 associated respiratory failure, required ventilatory support more than four weeks, which causes side-effects such as prolonged rehabilitation as well as severe critical illness and neuropathy 5.
Tracheostomy is a widely used intervention in patients with acute respiratory failure needing for prolonged IMV, but so far, no recommendation on COVID-19-affected patients exists[i].
At the moment there are at least three unsolved questions regarding the execution of tracheostomies in COVID-19 patients.
The first concerns the prognosis of patients admitted to intensive care for COVID-19. Severe and critical illness occurred in approximately 20% of the patients after admission to hospital5. In order to decide whether to tracheostomize patients, it would be important to define prognostic survival indicators.
In contrast with Grasselli et al6, in our preliminary study elder age and coexisting medical condition were not associated with greater risk of poor outcome. On the other side in accordance with Zhou our preliminary experience identified as risk factors for COVID-19 mortality the high SOFA score and increased D-dimer 19. Further studies are needed to better understand this association, but clinicians should be aware that for patients with SOFA score higher than 6, and D-Dimer level higher than 4 tracheostomy could be not indicated or at least should be postponed.
The second problem concerns the timing of the execution of this operation[ii] [iii]: “Can an early tracheostomy improve the survival of patients since it reduces the ventilatory dead space, decreases the probability of ventilator pneumonia, decreases the stay in the ICU, decreases the probability of developing septic shock and CID19?” In such a serious escalating pandemic, the aim in treating patients with COVID 19 disease is to maximize the likelihood of recovery as quickly as possible for the greatest number of patients.
In some hospitals, due to short supply of resources such as ventilators and sedatives, an early tracheostomy, within 7 days of intubation, was initially proposed to be performed to reduce the patient's need for sedation and to allow for an earlier transfer to the sub-intensive area. Others argued that reducing sedation and partially returning the patient to spontaneous breathing could cause negative effects on oxygenation and respiratory pattern29. Furthermore, Chao et al. 2020 suggest to wait beyond 21 days for the viral load to decrease and to avoid unnecessary tracheostomies in particularly critically ill patients30.
The American Academy of Otolaryngology-Head and Neck surgery suggests that tracheostomy should be performed after 14 days of endotracheal intubation, but there is no evidence as to the optimal timing of tracheostomy31.
Although outcome data on prone positioning in COVID-19 (used in 12% of patients in one ICU study from Wuhan) are currently lacking, the tendency for SARS-CoV-2 to affect the peripheral and dorsal areas of the lungs provides the ideal conditions for a positive oxygenation response to prone positioning32. .Considering that some patients have to be prone in some cases for even 10 days and that tracheostomy within the first 24 hours is a relative contraindication to pronation it would be better to wait at least 10 day to perform tracheostomy33.
The timing of tracheostomy is yet to be defined in such critically ill patients, but our results and recommendations worldwide would suggest performing a tracheostomy after at least 14 days of endotracheal intubation in patients who are unable to be weaned by ventilator but who have sufficient chances of survival.
Considering that in our study mean time from intubation to death was 21 days, for patients with higher SOFA score and higher d-dimer level, we suggest to wait until 21 days to decide for tracheostomy in order to avoid clinically vain procedures for patients and to rule out health care workers from worthless exposure risks.
The third problem concerns the viral load of COVID 19 and the infectious capacity of the virus.
In Italy at April 5th, 12,252 health workers have tested positive for COVID-19, resulting of 10% of Italy’s COVID-19 cases; at the time we were writing, 165 medical doctors and 40 nurses have died34 35. In China, more than 3,300 healthcare workers were infected (4% of the 81,285 reported infections). In Spain on the 25th March, nearly 6500 medical personnel were infected, 13.6% of the country’s 47,600 total cases, 1% of the health system’s workforce36.
As an aerosol generating procedure, tracheostomy increases healthcare worker exposure to COVID-19 infection, but the duration of viral load and correlation with transmission rate is not yet precisely known37.
Literature data show how the virus can remain in the body for up to two months 7. However, in some cases it may not be clinically or practically feasible to wait for a negative result prior to undertaking tracheostomy.
Our preliminary experience and early experience from other Italian26 38 and Chinese39 studies supports the safety of tracheostomy if appropriate protocols are strictly followed. After one month from the last tracheostomy we performed no one of our team developed symptoms of COVID-19. Specifically, recommendations contained in “Safe tracheostomy for patients with severe acute respiratory syndrome” revealed to be safe in our experience. The dress and undressing procedures and the use of specific DPI were of fundamental importance and limit the infections among clinicians; moreover, having a dedicated experienced team to fulfill tracheostomies will allow familiarity with the procedure, curtail the risk of contamination and decrease setup time.
This study has several limitations. First, our study might have selection bias because it was a single-center, retrospective study, with limited sample size, even if it had sufficient power to detect the significant differences between groups in mortality. Second, there is no assessment of the follow-up effect of the SARS-CoV-2 on discharged patients, although patients in this study were thought to have definite outcomes. Third, for the greater propensity in our hospital to perform surgical tracheostomies, it was not possible to carry out an analysis and comparison with percutaneous tracheostomies.
Finally due to the short follow-up we don’t have data of beneficial effect of tracheostomy on long-term mortality and on the potential complications associated with tracheostomy; thus, further studies focusing on long-term outcomes are warranted.
The strength of our study is that is the first case series to report data on such a threatening issue and might help clinicians worldwide who will soon be dealing with the same challenges.