Abstract
This review explores the current body of evidence pertaining to tracheostomy placement in COVID-19 seropositive patients and summarizes the research by tracheostomy indications, timing, and procedure. Literature review was performed in accordance with the 2020 PRISMA guidelines and includes 12 papers discussing protocols for adult patients seropositive for COVID-19. The studies demonstrated high mortality rates after tracheostomy, especially in geriatric patients, and suggested a multifactorial determination of whether to perform a tracheostomy. There was inconclusive data regarding wait time between testing seropositive, tracheostomy, and weaning off of ventilation. COVID-19 generally reaches highest infectivity between days 9 and 10; furthermore, high early mortality rates seen in COVID-19 may confound mortality implicated by tracheostomy placement. Due to the aerosol-generating nature of tracheostomy placement, management and maintenance, techniques, equipment, and personnel should be carefully considered and altered for COVID-19 patients. With surgical tracheostomy, literature suggested decreased usage of electrocautery; with percutaneous tracheostomy, single-use bronchoscope should be used. The nonemergent exchange of tracheostomy should be done only after the patient tested negative for COVID-19. Placement of tracheostomy should only be considered in COVID-19 patients who are no longer transmissible, with rigorous attention to safety precautions. Understanding procedures for airway maintenance in a respiratory disease like COVID-19 is imperative, especially due to current shortages in ventilators and PPE. However, because of a lack of available data and its likelihood of change as more data emerges, we lack complete guidelines for tracheostomy placement in COVID-19 seropositive patients, and those existing will likely evolve with the disease.
Keywords: tracheostomy, timing of tracheostomy, COVID-19 infection, trauma outcomes
Introduction
The utility of performing tracheostomy in the critical care setting is well-established, especially as a means of maintaining airway access for mechanical ventilation.1,2 The timing of tracheostomy placement is a necessary consideration because early placement has been correlated with decreased overall time on mechanical ventilation and therefore decreased sedation.3,4 Even the definitions describing the timing of tracheostomy placement—usually early, intermediate, and late—are not homogenized between organizations, institutions, or clinicians. Previous literature has established that increased time on mechanical ventilation is associated with longer times in the intensive care unit (ICU) and also increased rates of nosocomial infections, like ventilator-associated pneumonia (VAP), which may, in turn, adversely affect mortality rates in these patients. 5
Situations in which special considerations must be made about the decision to perform a tracheostomy include the current COVID-19 pandemic, especially considering tracheostomy is an aerosol-generating procedure with risk of transmission of respiratory infections. 6 This is especially true considering the previous literature has suggested that the timing of tracheostomy placement may impact outcomes in patients with respect to ICU-length of stay (LOS) and short-term mortality. 7 Existing evidence from current literature review of available data concerning tracheostomy indications in COVID-19 positive trauma patients may aid in the development of consensus between organizations, medical institutions, and clinicians, as well as elucidate potential gaps in the literature and currently available guidelines from major trauma organizations. The potential for fewer days on mechanical ventilation with appropriate timing of tracheostomy in COVID-19 patients is of particular relevance and may help with reducing ventilation days, ICU bed shortages, and reduce overall mortality. The purpose of this review is to provide evidence regarding the placement of tracheostomy in COVID-19 seropositive patients.
Patients and Methods
Data Sources and Search Strategy
For this review, a search of PubMed, Google Scholar, and JAMA Network databases was done to identify studies that evaluated the placement of tracheostomies in COVID-19 patients between January 2019 and May 2021 (Figure 1). The search terms used for this critical review included: early tracheostomy, tracheostomy indications, and COVID-19. This search was limited to those that were either published in English or were translated to English. The primary search for this literature review was conducted in March 2021 and the secondary search in May 2021.
Figure 1.
PRISMA flow chart for studies included in this review.
Study Selection and Eligibility Criteria
Studies were limited to adults (age ≥ 18), as well as patients presenting with COVID-19. All articles were initially screened for overall relevance. References from included articles were also searched for relevant manuscripts. Exclusion criteria included duplicate articles, non-English language articles, short notes, and letters. There were no limitations to study selection in sample size. Studies were also excluded if they lacked outcome measurements or data on tracheostomy being performed on the COVID-19 population. Search was conducted in accordance with 2020 PRISMA Guidelines.
Data Collection Process
Authors J.M., A.E., C.C., and M.M. conducted the primary literature search, screened the articles, extracted data from the full-text articles, and resolved discrepancies in opinion. The data extracted included study citation, year, location, U.S. vs non-U.S. institution, study design, patient population, protocol for tracheostomy placement (including timing, indications, and contraindications), incidence of secondary comorbid conditions in patients, incidence of patient mortality, and study limitations.
Outcome Measurements
Our primary objective was to explore the literature discussing protocols and indications for tracheostomy in COVID-19 seropositive patients to determine whether the timing (eg, early, intermediate, or late) affects patient development of VAP, patient morbidity, and mortality.
Results
The Current Evidence Describing Tracheostomy Indications in the Setting of COVID-19
Overall, 12 studies met inclusion criteria and were selected for this review, including those concerning adult patients (age ≥ 18) who were COVID-19 positive (Table 1). Literature discussing individual case studies, surveys, and letters were excluded. Literature discussing tracheostomy both generally and in the setting of COVID-19 consisted primarily of literature reviews, retrospective cohort and observational studies, and multidisciplinary reviews published in English between January 2006 and May 2021.8-19
Table 1.
Summarizes Studies Pertaining to Tracheostomy Outcomes in the Setting of COVID-19 and Details Current Recommendations.
First author, year | Name | Study type | Population | Demographics | N | Outcome measures | Recommendations | Timing | Tracheostomy Technique |
---|---|---|---|---|---|---|---|---|---|
Chao T. et al, 2020 | Outcomes after tracheostomy in COVID-19 patients | Prospective single-system multicenter observational cohort study | COVID-19 population; single-system, multicenter within the University of Pennsylvania Health System | Adults age >18; average age 62 years | 53 | Indications for tracheostomy; tracheostomy technique; viral transmission during procedure | Most common indication: ARDS, followed by attempt to wean off ventilation without ARDS; patients fully paralyzed to prevent aerosolization | Mean day 19.7 post-endotracheal intubation | Open and percutaneous were both performed |
Zhang X. et al, 2020 | Safe and effective management of tracheostomy in COVID‐19 patients | Retrospective observational analysis | COVID-19 population; Union Hospital (West Branch) of Huazhong University of Science and Technology (Wuhan, China) | Adults age >18; average age 66 years | 11 | Patient selection; surgical technique and complications; adjuvant therapy | Elective tracheostomy should be considered when extubation cannot be performed >7 days s/p endotracheal intubation | Mean hospitalization day 26.6 in patients with endotracheal intubation and mechanical ventilation | Percutaneous was preferred, with open technique for difficult airways |
Kwak P. et al, 2020 | Early outcomes from early tracheostomy for patients with COVID-19 | Retrospective cohort study | COVID-19 population, single-center in NY | Adults age >18; mean age 58.1 years | 148 | Patient selection; tracheostomy timing; length of ICU stay | ET (<10 days) was significantly associated with shorter hospital stays (40 days vs 49 days; median difference, −8; 95% CI, −15 to −1); late tracheostomy was 16% less likely to discontinue mechanical ventilation | Mean time from symptom onset to intubation: 10.57 days; mean time from symptom onset to tracheostomy: 22.76 days | Percutaneous was preferred, with open technique for difficult airways |
Picetti E. et al, 2020 | Safety of bedside surgical tracheostomy during COVID-19 pandemic: A retrospective observational study | Retrospective observational analysis | COVID-19 population; single-center | Adults age >18; mean age 58.7 | 66 | Tracheostomy timing; intraoperative complications; postoperative complications; tracheostomy at ICU discharge; respiratory parameters before and after tracheostomy | Performing early bedside tracheostomy yields no significant increase in secondary complications | Mean time from ICU admission to tracheostomy: 6.1 days, which they classify as “early” | Surgical bedside tracheostomy |
Volo R. et al, 2021 | Elective tracheostomy during COVID-19 outbreak: To whom, when, how? Early experience from Venice, Italy | Retrospective cohort study | COVID-19 population; single-center Angel Hospital and Saints Giovanni e Paolo Hospital | Adults age >18; mean age 69 | 23 | Patient selection; tracheostomy timing; length of ICU stay; mortality; virtual transmission; D-dimer | Tracheostomy should not be performed until at least 14 days after endotracheal intubation; contraindications for tracheostomy: SOFA score >4, D-dimer >4; early tracheostomy patients had significantly higher risk of death (P=.077) | Early tracheostomy: <10 days; late tracheostomy >10 days; average mean time between intubation and tracheostomy was 13 days | Preference for surgical tracheostomy over percutaneous |
Long S. et al, 2021 | Percutaneous and open tracheostomy in patients with COVID-19: Comparison and outcomes of an institutional series in New York city | Prospective institutional study | COVID-19 population; single-center in NY | Adults age >18; mean age 66 | 67 | Patient selection; tracheostomy timing; perioperative conditions; mortality | No differences in outcomes between open vs percutaneous technique | Median time from intubation to tracheostomy: 23 days | No significant differences in open vs Percutaneous technique |
Avilés-Jurado F. et al, 2021 | Timing, complications, and safety of tracheostomy in critically Ill patients with COVID-19 | Prospective cohort study | COVID-19 population; single-center | Adults age >18; mean age 63.9 | 50 | Tracheostomy timing; tracheostomy technique; safety measures takes, viral transmission; postoperative complications; time on mechanical ventilation | Early bedside tracheostomy may reduce time on mechanical ventilation (mean 18 days vs 22.3 days; adjusted HR 4.04, 95% CI, .93-17.54) | Early tracheostomy: <10 days; late tracheostomy >10 days; average mean time between intubation and tracheostomy was 9 days | Bedside open tracheostomy |
Tang Y. et al, 2020 | Tracheostomy in 80 COVID-19 patients: A multicenter, retrospective, observational study | Retrospective observational study | COVID-19 population; multicenter in Hubei province, China | Adults age >18; mean age 63.9 | 80 | Patient selection; comorbid conditions; respiratory parameters; renal and liver parameters; tracheostomy procedure; location | Increased mortality rates in patients receiving ET (<14 days) compared to late (P=.007) | Early tracheostomy: <14 days after intubation; late tracheostomy >14 days after intubation; median days from intubation to tracheostomy: 17.5 days | Percutaneous technique performed |
Mahmood K. et al, 2021 | Tracheostomy for COVID-19: Multidisciplinary, multicenter data on timing, technique, and outcomes | Multicenter, retrospective study | COVID-19 population | Adults age >18 | 118 | Median ventilator days; ICU duration; hospital length of stay | ET decreased median ventilator days (21 vs 37); percutaneous technique (vs Surgical) associated with faster weaning times off the ventilator (P=.038); decreased VAP (58.7% vs 80.8%); shorter ICU duration (33 vs 47); shorter hospital length of stay (46 vs 59.5 days) | Early tracheostomy: <14 days | Percutaneous technique (vs Surgical) |
Goldstein C. et al, 2021 | Tracheostomy is safe in patients with prolonged intubation after coronavirus disease 2019 infection | Single-institution, case series | COVID-19 population on ventilation >3 weeks | Adults age >18 | 15 | In hospital mortality; timing of liberation from ventilator; tracheostomy removal; length of ICU stay | Prolonged ventilation is necessary in COVID-19 patients (average of 14 days to liberation post-tracheostomy) | Tracheostomy placement at an average of 31 days post-intubation | NR |
Sun B. et al, 2020 | Modified percutaneous tracheostomy in patients with COVID-19 | Single-institution, retrospective review | COVID-19 population | Adults age >18 | 12 | Median time to tracheostomy; post-tracheostomy complications and mortality; healthcare worker transmission | Percutaneous tracheostomy can be performed in a modified fashion on COVID-19 patients | Median time to tracheostomy 17 days | Percutaneous technique |
Martin-Villares et al, 2020 | Outcome of 1890 tracheostomies for critical COVID-19 patients: a national cohort study in Spain | Multicenter prospective observational study | COVID-19 population | Adults age >18 | 1890 | Postoperative complications; weaning and decannulation and survival | 52.1% patients were weaned off of ventilation at 1-month follow-up | Median time to tracheostomy 12 days | Surgical and percutaneous |
General Precautions
The COVID-19 pandemic continues to evolve rapidly. Much of the data and the conclusions drawn from those data come from Wuhan, China, or other settings where the populations were affected early in the course of pandemic. 20 Additional insights for dealing with COVID-19 have been drawn from the 2002 SARS-CoV-1 epidemic.20-22 Given the nature of this novel coronavirus, which is spread by respiratory droplet, and the aerosol-generating nature of tracheostomy placement, especially strict precautions are recommended for COVID-19 patients requiring ventilation.23,24 Both the American Association for the Surgery of Trauma (AAST) and the Eastern Association for the Surgery of Trauma (EAST) have posted or endorsed guidelines specific to tracheostomy in the setting of COVID-19 on their respective webpages.25,26
Patient Selection
According to Michetti et al, major considerations for determining whether or not to perform a tracheostomy in this population should ideally be informed by large-scale triage and should otherwise include viral shedding as patients with active COVID-19 should not undergo tracheostomy until they are no longer transmissible. 23
In their single-center retrospective review, Volo et al, report that a critical illness developed in 20% of patients admitted with a positive COVID-19 status. 12 Furthermore, Chao et al, report that the most common indication for tracheostomy placement in COVID-19-positive patients was acute respiratory distress syndrome (ARDS). 8 Given that the long-term mortality in patients undergoing tracheostomy placement with COVID-19 is < 50%, the decision to place the tracheostomy should be multifactorial. 13 According to Zhang et al, the majority of patients undergoing tracheostomy had a comorbid condition, such as hypertension, diabetes, or cardiac disease, and all patients studied had an underlying coagulopathy, (eg, coagulation function abnormity, a D-dimer abnormality, thrombocytopenia, or liver or renal function abnormality). 9
Michetti et al cite a 1-year mortality of 46.5% overall and 54.7% for those over age 65. 23 The high risk associated with this procedure necessitates both a patient- and family-centered approach. Additional considerations include patient stability and mobility in determining amenability to the procedure. Percutaneous tracheostomy is more commonly chosen over open tracheostomy in COVID-19 patients. In obese patients or those with other complicating comorbid factors, transport to the operating room should be considered unless there is substantial risk for transmissibility during transport.
Timing
The American Academy of Otolaryngology-Head and Neck Surgery has recommended that tracheostomy not be performed in COVID-19-positive patients prior to 14 days post-endotracheal intubation. 27 These timelines were primarily based on data suggesting that peak infectivity for COVID-19 is between 9 and 10 days. 10 However, studies from Volo et al and Avilés-Jurado et al considered 10 days as early tracheostomy with average mean days between intubation and tracheostomy of 9 and 13 days, respectively.12,14 Furthermore, a single-center retrospective study by Picetti et al, suggested that performing open tracheostomy at a mean of 6 days demonstrated low rates of complications, which is in contrast to much of the early literature on the topic. 11 Additionally, none of the members involved in the tracheostomy procedures developed COVID-19. 11 This shorter wait time is justified by inconclusive data in the available literature of a causal relationship between early tracheostomy and the development of complications such as VAP.11,28 Avilés-Jurado et al and others have suggested in their studies that early tracheostomy is positively correlated with a decreased number of days on mechanical ventilation (adjusted hazard ratio 2.55; 95% CI, .96-22.3), although not statistically significant.14,16
In contrast to much of the current data which primarily discusses patients receiving tracheostomy between days 10 and 21, in their case series, Goldstein et al, explore postoperative morbidity and mortality in COVID-19 seropositive patients after 21 days of ventilation. 17 In their study, they suggest that the later timing of the tracheostomy confers a lower mortality rate (13% vs 88%), potentially due to survivor bias, as the patients who previously died were not eligible for a tracheostomy. 17 These patients had already survived the early phase of their COVID-19 infection, which, by its nature, confers lower mortality. This is further supported by the large multicenter prospective study conducted by Martin-Villares et al, whose study noted a median time to ventilation of 12 days, with 52.1% having been successfully weaned off ventilation at 1-month follow-up. 19
Location, Equipment, and Technique
If the determination is made to place a tracheostomy in a patient with COVID-19, the setting in which the procedure is conducted should be rigorously maintained. Ideally, placement of a cuffed, non-fenestrated tracheostomy tube should be performed in a negative pressure airborne infection isolation room (AIIR); otherwise, the procedure should be done in a setting isolated for at least 3 hours to minimize transmission of aerosols. 21 Non-essential personnel and additional equipment should be accessible but not in the room where the procedure is being performed.
The decision to perform surgical or percutaneous tracheostomy is largely situational; however, Picetti et al, describe that their rationale for choosing to perform primarily surgical tracheostomy is based on pre-COVID-19 preference, as well as the reduced risk of aerosolization during these procedures. 11 During open procedures, electrocautery should be avoided due to its higher propensity for aerosolization. During percutaneous procedures, the decision to perform a bronchoscopy for visualization should be made by the surgeon and, if used, should be done with a single-use bronchoscope. Alternatives include manual palpation for localization, Doppler, and aspiratory needle to confirm tracheal placement. In contrast to patients without COVID-19, those with active or suspected disease should undergo neuromuscular blockade prior to tracheostomy to prevent droplet dissemination, in addition to full sedation and analgesia. Additionally, until a new airway is established and the tracheostomy cuff is inflated. During the transition to the new tracheostomy, ideally if possible ventilation should be held and/or the patient should be temporarily ventilated via bag-valve mask. Additionally, the ventilator parameters for consideration of a tracheostomy placement in patients with COVID-19 include a positive end expiratory pressure (PEEP) < 12 and fraction of inspired oxygen (FiO2) < .60. 29
Per current CDC guidelines, even in emergent cases, proper PPE should still be used (eg, double-gloving and, in some cases, double-gowning) and respirator masks should be worn to mitigate risk via aerosol exposure. Ideally, N95 masks should be worn under a powered air purifying respirator (PAPR) for best protection from airborne viral exposure; however, an N95 with face shield and eye protection may be used in the absence of PAPR.
The Western Trauma Association (WTA) has posted discussion of the management of critical conditions in the setting of COVID-19 but lacks pointed discussion or guidelines for tracheostomy placement.
Management of Tracheostomy
The most common postoperative complication appears to be tracheostomy bleeding.14,15,18 In general, any unnecessary or elective aerosol-generating procedures should be avoided. Many further management techniques, such as frequency of inner cannula change and use or disuse of moisture and heat exchange filters, should be made on an individualized basis and with rigorous attention to risk mitigation. Literature review conducted by Heyd et al, suggests that any tracheostomy change be limited until after the patient tests negative for COVID-19. 30
Discussion
This uncertainty surrounding tracheostomy placement in COVID-19 patients is compounded by a lack of consensus within the medical community regarding optimal timing for tracheostomy placement in critically ill patients who are not COVID-19 seropositive. Major trauma organizations, including EAST, discern no difference in mortality between early tracheostomy placement (3-7 days) and late. 27
In such a severe context as acute respiratory failure, tracheostomy may be performed in patients who require prolonged mechanical ventilation; however, due to the newness of the COVID-19 pandemic and its rapid evolution, there is a lack of high-level evidence surrounding tracheostomy placement. 31 Due to the mechanism of disease spread seen with COVID-19, the general consensus in current literature suggests that tracheostomy should be avoided in patients with active COVID-19 infections due to potential disease dissemination during the procedure. In general, elective procedures are recommended to be postponed, and if tracheostomy is necessitated, COVID-19 testing should be done 48 hours prior to tracheostomy placement. 30 In COVID-19 patients who are no longer transmissible, tracheostomy should still be placed only in emergent settings, with only essential personnel and equipment present, and with rigorous attention to PPE and sanitation. 23 Some literature has suggested that an open procedure may be preferable over a percutaneous method; however, the choice of which type of procedure to perform, as well as whether to perform the tracheostomy placement at all, should largely be based on staff expertise, equipment, and comfort. 13
Much of the available literature is in line with the current standards set by the American Academy of Otolaryngology-Head and Neck and suggests that tracheostomies should not be performed until 14 days after intubation to minimize transmissibility of the COVID-19 virus. 32 However, it should be noted that these recommendations were created during the early stages of the pandemic before comprehensive studies could investigate tracheostomy timing. Additionally, the suggestions that early tracheostomy in patients with COVID-19 should be avoided was based on the assumption that a higher viral load would be present at that time. 32 However, according to Schultz et al, RT-PCR may amplify dead or inert virus with no evidence of increased transmission comparing between 10 or > 21 days, leading to the misconception that early tracheostomy is associated with increased risk to health care workers. 33 The literature also lacks robust data exploring patients who receive tracheostomy past 20 days of symptom onset, which, especially in light of these recommendations to delay placement, will become essential moving forward. 32 Some papers have suggested that a week is reasonable to prepare a multidisciplinary team to perform a tracheostomy from the time of initial presentation; however, this does not necessarily correlate to the time from initial symptom onset.33,34
Since much early data came from China, in and around Wuhan, application of these guidelines and procedures may need to be modified depending on intercontinental differences and access to care and resources. As new data emerge and the established trauma and critical care organizations, such as AAST, EAST, and WTS, hone and develop their guidelines for performing tracheostomies under these new conditions, the procedure for tracheostomy placement in the setting of COVID-19 may homogenize and provide benefits in both short- and long-term survival.
Major trauma organizations, such as WTA, AAST, and EAST, provide guidelines discussing tracheostomy placement in a variety of settings; however, in respect to tracheostomy placement in COVID-19 seropositive patients, there is a lack of depth of discussion in the literature compared to other medical emergencies such as TBI.35-37
Understanding procedures for airway maintenance in a critical respiratory disease such as COVID-19 is imperative due to shortages in ventilators and PPE and the potential for infected patients to overwhelm the hospital setting. Therefore, determining ways to decrease time to weaning from mechanical ventilation has both fiscal and humanitarian benefits. However, using tracheostomy placement in patients with other critical conditions as an example, analyzing data from a special subpopulation of those receiving tracheostomy, even with decades of data and meta-analysis conducted, conclusive guidelines and procedures may still present a challenge for development.
Some of the major difficulties to be addressed as a point of future study may include guidelines homogenizing the definitions of terms such as COVID-19 and early vs intermediate vs late tracheostomy. In addition, expanding on available prospective data from COVID-19 patients and those receiving tracheostomy at greater than 20 days past infection is imperative as there is a paucity of current evidence. Unifying these definitions, exploring unknowns in the course of the disease on an individual level and developing preparedness protocols will be essential moving forward. Together, these may allow for improvement in the scientific method for the conduct and analysis of further data, which will be of vital importance as new data from current COVID-19 patients become rapidly available.
Limitation of Current Evidence
In some of the studies noted in this review, a definitive statement about mortality could not be made due to the low number of patient deaths in the analyzed cohort. 3 The number of patients in each of the single-center studies varies greatly, further limiting the power of studies with smaller sample sizes. Apart from conclusions that were drawn based on dealing with the SARS-CoV-1 pandemic, there is a paucity of data analyzing the current set of patients in the critical care setting receiving tracheostomy, and many of those available have small sample sizes and are limited to the patient population at one hospital. Another limitation is the lack of knowledge and consensus surrounding how long COVID-19 patients require ventilation. 18 As new data describing the COVID-19 population emerge, current guidelines may change.
Conclusion
There is a lack of robust and prospective data describing tracheostomy timing in the setting of COVID-19 and its association with decreased mechanical ventilator days, decreased rate of ventilator-associated pneumonia, or changes in long-term mortality outcomes. If the determination to perform a tracheostomy is made, placement should be done with rigorous adherence to safety and exposure-limiting protocols. Tracheostomy in the setting of COVID-19 should be performed past the peak window for viral exposure, after 14 days have elapsed since endotracheal intubation, which is considered by most texts to be “late” and these data should be supplemented by future studies describing tracheostomy placement past 20 days as the pandemic continues to perverse and evolve.
Author contribution: Study Design and Conception: Data AE. Collection, Interpretation and Analysis: JM, KC, AE, KN, and Manuscript MM. Preparation: JM, KC, and Critical AE. Revision of Manuscript: AE, JM, KC, KN, and MM.
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
Ethical Approval: All authors read and approved the final manuscript.
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