key: cord-0754035-3jz7zhkj
authors: Carlson, Eric R.; Heidel, R. Eric; Houston, Kyle; Vahdani, Soheil; Winstead, Michael
title: Tracheotomies in COVID-19 patient2 Protocols and outcomes
date: 2021-03-12
journal: J Oral Maxillofac Surg
DOI: 10.1016/j.joms.2021.03.004
sha: 0e5f6de2394bd5bbbe48f203307d76737b5fd191
doc_id: 754035
cord_uid: 3jz7zhkj

PURPOSE: Approximately 3-15% of COVID-19 patients will require prolonged mechanical ventilation thereby requiring consideration for tracheotomy. Guidelines for tracheotomy in this cohort of patients are therefore required with assessed outcomes of tracheotomies. PATIENTS AND METHODS: A retrospective chart review was performed of COVID-19 patients undergoing tracheotomy. Inclusion criteria were the performance of a tracheotomy in COVID-19 positive patients between March 11 and December 31, 2020. Exclusion criteria were lack of consent, extubation prior to the performance of a tracheotomy, death prior to the performance of the tracheotomy; and COVID-19 patients undergoing tracheotomy who tested negative twice after medical treatment. The primary predictor variable was the performance of a tracheotomy in COVID-19 positive patients and the primary outcome variable was the time to cessation of mechanical ventilation with the institution of supplemental oxygen via trach mask. RESULTS: Seventeen tracheotomies were performed between 4-25 days following intubation (mean=17 days). Seven patients died between 4-6 days (mean=8.7 days) following tracheotomy and 10 living patients realized cessation of mechanical ventilation from 4 hours to 61 days following tracheotomy (mean=19.3 days). These patients underwent tracheotomy between 4-22 days following intubation (mean=14 days). The 7 patients who died following tracheotomy underwent the procedure between 7-25 days following intubation (mean=18.2 days). Seven patients underwent tracheotomy on or after 20 days of intubation and 3 survived (43%). Ten patients underwent tracheotomy before 20 days of intubation and 7 patients survived (70%). Significant differences between the mortality groups were detected for age (p=0.006), and for P/F ratio at time of consult (p=0.047) and the time of tracheotomy (p=0.03). CONCLUSION: Tracheotomies are safely performed in COVID-19 patients with a standardized protocol. The timing of tracheotomy in COVID-19 patients is based on ventilator parameters, P/F ratio, patient prognosis, patient advanced directives, and family wishes.

Tracheotomies are safely performed in COVID-19 patients with a standardized protocol.

The timing of tracheotomy in COVID-19 patients is based on ventilator parameters, P/F ratio, patient prognosis, patient advanced directives, and family wishes.

The coronavirus disease , caused by the severe acute respiratory syndrome septic shock, and multi-system organ failure 3, 4 . Approximately 25% of all COVID-19 positive patients have medical comorbidities and it has been estimated that 60-90% of hospitalized COVID-19 positive patients have medical comorbidities 4 . These diagnoses in hospitalized patients include hypertension, cardiovascular disease, diabetes, chronic kidney disease, chronic pulmonary disease, cancer, and chronic liver disease [5] [6] [7] .

Approximately 17-35% of hospitalized COVID-19 patients are admitted to an intensive care unit, primarily due to hypoxemic respiratory failure 4 . Greater than 75% of hospitalized COVID-19 patients require the administration of supplemental oxygen and 3-15% of COVID-19 patients will require mechanical ventilation 1, 8 . An early report indicated that death was common in patients who were mechanically ventilated. In a study of 52 critically ill COVID-19 patients, thirty (81%) of 37 mechanically ventilated patients were dead by 28 days 9. Moreover, there were no intubated patients who were extubated and alive at the end of the study. Another study reported on 191 hospitalized COVID-19 patients of which 137 were alive and 54 were dead. Thirty-two patients (17%) were mechanically ventilated, of which 31 patients died and 1 patient survived 10 . It becomes clear, therefore, that the prognosis of mechanically ventilated COVID-19 patients is poor and some patients require long periods of ventilator support. Tracheotomy might be beneficial to these patients, particularly those who otherwise have a favorable prognosis. The surgical intervention of tracheotomy might also be indicated since COVID-19 has become the leading cause of death in the United States 11, 12 . Since tracheotomy is 1 of the final efforts to be offered to mechanically ventilated intensive unit care patients in general, consideration should certainly be given to performing tracheotomies in COVID-19 patients who are similarly experiencing prolonged periods of mechanical ventilation. In doing so, however, the health care team must be protected from transmission of the disease, the concern for which has produced anxiety in these individuals 13 . The purpose of this study was to outline protocols and safety measures taken to protect all members of the health care team while determining the outcomes of COVID-19 patients undergoing tracheotomy, particularly regarding cessation of mechanical ventilation with transitioning to supplemental oxygen in these patients.

A retrospective chart review was conducted of all patients undergoing tracheotomy by a single surgeon (ERC) of the Department of Oral and Maxillofacial Surgery at the University of Tennessee Medical Center from the beginning of the pandemic, March 11, 2020 through December 31, 2020.

University of Tennessee Institutional Review Board (IRB) review and approval was obtained to conduct the study (IRB #4712). Study patients were those who were consulted for tracheotomy by the surgeon from t3 intensive care units in the hospital, including the Cardiovascular Intensive Care Unit (CVICU), the Medical Intensive Care Unit (MICU), and the Neuro Intensive Care Unit (NCC) where COVID-19 patients were primarily admitted. Consults were placed by intensivists when their efforts to successfully provide ventilator wean and extubation of patients failed to come to fruition, thereby necessitating tracheotomy for continued mechanical ventilation and ventilator weaning. The threshold and timing for consultation varied in terms of the patient's length of time intubated. This threshold was arbitrary among the critical care physicians primarily caring for these patients, and was therefore very individualized.

Inclusion criteria for the study were patients who tested positive for COVID-19 at least once during their hospital admission and who underwent tracheotomy. Exclusion criteria were patients who were not tested for COVID-19, patients who were negative by 2 tests prior to the tracheotomy procedure, and patients who underwent tracheotomy before the designation of the pandemic on March 11, 2020 or after December 31, 2020. The primary predictor variable of the study was a mechanically ventilated COVID-19 positive patient who underwent a tracheotomy. The primary outcome variable of the study was the time to cessation of mechanical ventilation with the institution of supplemental oxygen via trach mask following tracheotomy.

All patients admitted to the University of Tennessee Medical Center since the designation of the pandemic on March 11, 2020 undergo COVID-19 nasopharyngeal swab sampling, including those patients directly admitted to an intensive care unit. The SARS-Co-V-2 assay manufactured by Intergy Laboratories (Knoxville, Tennessee) was utilized in the assessment of patients at the University of Tennessee Medical Center beginning on March 19, 2020. The Xpert Xpress SARS-Co-V-2 test (Cepheid; Sunnyvale, California) was utilized beginning in mid-April 2020, and the Panther Fusion SARS-C0-V-2 assay (Hologic, Inc.; Marlborough, Massachusetts) was used effective June 29, 2020, and continued to be used at the time of the completion of this study. While all patients underwent testing upon admission, non-uniform testing occurred thereafter. Some patients underwent repeat testing following a positive test result in preparation for tracheotomy, while some patients did not undergo repeat testing. All COVID-19 patients underwent chest imaging with plain films and CT scans without intravenous contrast. All symptomatic patients underwent CT angiograms of the chest to rule out pulmonary emboli.

All patients were medically assessed preoperatively by the critical care team, the oral and maxillofacial surgery team, and the anesthesia team in terms of the ideal time to perform the tracheotomy following consultation. While strict ventilator parameters [maximum rate in breaths per minute, maximum positive end-expiratory pressure (PEEP), and maximum fraction of inspired oxygen (Fi0 2 )] varied in terms of suitability for the tracheotomy procedure, the 3 teams agreed on a Pa0 2 /Fi0 2 (P/F) of 100 or greater as an absolute standard to proceed.

All tracheotomy procedures were performed in an operating room with an anteroom located immediately adjacent to the operating room. The anteroom contained an inside door permitting entrance directly to the operating room and an exit door to the main hallway. Entrance to and exit from the operating room to the hallway can occur through the anteroom or directly through the operating room.

Team members entered and exited the operating room, however through the anteroom rather than the front door to the operating room proper. In this manner, any potentially aerosolized virus in the operating room would be better contained within the operating room, rather than disseminating to the main hallway outside the operating room where other OR personnel not involved in the case might otherwise be exposed to aerosolized virus. Stated differently, the front door to the operating room was not opened during the procedure, but only permitted entrance and exit of the patient before and following the procedure. A 17-minute delay occurred by hospital protocol following all COVID-19 tracheotomy procedures before opening the front door to the operating room and transporting the patient back to the ICU. Additionally, the door from the anteroom to the operating and the door from the anteroom to the main hallway were never simultaneously opened. This protocol prevented aerosolized virus present in the operating from disseminating to the main hallway outside the operating room through the anteroom. The anteroom contained the scrub sinks and represented the area where doffing of the surgical team's personal protective equipment (PPE) occurred following the procedure.

All tracheotomy procedures were rehearsed with the 2 circulator nurses and 1 surgical technologist familiar with the team's standardized routine. Due to the short nature of the procedure, as well as the intention to limit team member exposure to the patient, this staff was not replaced during the procedure. One circulator nurse was physically present in the OR during the procedure and the other circulator nurse was present in the anteroom for retrieval of additional supplies that might be required of the surgical team during the tracheotomy procedure.

Enhanced PPE was donned by all members of the support staff, surgical team, and anesthesia team. Enhanced PPE included an N95 mask, eye goggles or surgical loupes, a face/neck shield, surgical gown, and double gloves.

All tracheotomies were performed in the operating room under full sterile conditions, and all tracheotomies were open. A supramanubrial approach was uniformly executed and a standard dissection was performed of deep layers, identical to our approach for non-COVID patients 14 . Use of the electrocautery was minimized during the dissection. Use of the suction was similarly minimized during the procedure. The trachea was entered with an I incision and no suctioning of the airway occurred. 

All patients were administered long-acting neuromuscular blockade in the intensive care unit to avoid coughing during transport to the operating room and during the procedure. General anesthesia was administered through the existing endotracheal tube. Full and effective endotracheal cuff pressure was ensured prior to prepping the patient's skin. The heat and moisture exchanger (HME) was maintained on the endotracheal tube during the entirety of the case. The patient was maintained on 100% oxygen for most of the surgical procedure. Cessation of ventilation by the anesthesia team occurred upon request by the surgeon before the trachea was incised. Ventilation resumed immediately following hyperinflation of the tracheostomy tube cuff and verification of maintenance of cuff pressure. The HME was maintained on the circuitry connected to the tracheostomy tube. The patient was transported back to the ICU on 100% oxygen. The tracheostomy tube cuff pressure was converted from hyperinflation to conventional inflation thereafter.

Following completion of the surgical procedure, members of the surgical team, including the surgical technologist individually and sequentially entered the anteroom for doffing of PPE. A dedicated team member, present in the anteroom during the surgical procedure, assisted individual team members with incremental removal of PPE with wiping of gloves and hands with a virucidal wipe (Sani-Cloth AF3 germicidal disposable wipe; PDI, Woodcliff Lake, New Jersey), before and after each step. The first step was removal of the outer set of gloves. The virucidal wiping of the outer set of gloves took place before their removal. Thereafter, a virucidal wiping of the inner set of gloves occurred. The face/neck shield was removed followed by virucidal wiping of the inner set of gloves. The gown was then removed followed by virucidal wiping of the inner set of gloves that were then removed. Bare hands were cleaned by virucidal wiping followed by removal of surgical loupes that were then placed in the loupe box. The team member then washed hands at the scrub sink and the door from the anteroom to the hallway was opened for the team member. This sequence was identically repeated for each team member until all members were doffed and exited the anteroom. All team members then changed their scrubs and exited the operating room complex. Team members were encouraged to shower if blood or other body fluids touched their skin.

Descriptive and frequency statistics were performed to describe the sample's demographic and clinical characteristics. Statistical assumptions for continuous variables (normality and homogeneity of variance) were assessed before comparing the mortality groups (0 = lived versus 1 = died). There was a limited sample size for purposes of between-subjects analyses, and while non-parametric statistics could have been performed, the researchers chose to use parametric statistics to increase statistical power, as well as the precision of the statistical inferences. An adjustment was mace to the degrees of freedom when homogeneity of variance was violated so that parametric analyses could still be applied. Independent samples t-tests were performed to compare the mortality groups on age, BMI, P/F ratio at time of consultation, time to performance of tracheotomy after intubation, P/F ratio at time of tracheotomy, and time to consultation following intubation. Means and standard deviations were reported and interpreted for the t-test analyses. Statistical significance was assumed at an alpha value of 0.05 and the statistical analyses were conducted using SPSS Version 26 (Armonk, NY: IBM Corp.).

The retrospective chart review of all patients consulted for the tracheotomy procedure by the (table 1) . Of the 3 COVID-19 patients who did not undergo the tracheotomy procedure, 1 patient (patient 2) was successfully extubated the day prior to the intended procedure, and 2 patients (patient 3 and 5) died before the tracheotomy procedure could be performed (table 2) (table 3) . Of these 14 patients, the P/F was uniformly greater than 100 at the time of tracheotomy, and ranged from 101 to 341, with a range of 180. Only 1 study patient (patient 7) demonstrated a P/F greater than 300 at the time of consult and the time of tracheotomy.

The tracheotomies were performed with a range of 4 days to 25 days following intubation, with a mean of 17 days. Estimated blood loss associated with the tracheotomy procedures ranged from 5-20 mL with a mean of 10 mL. There was no intraoperative morbidity or mortality associated with the procedures. Numerous consensus and anecdotal guidelines recommended delaying tracheotomy, or avoiding the procedure entirely, to minimize the risk of transmission of the infection to team members caring for the patient 8, [15] [16] [17] [18] [19] . Specifically, avoiding early tracheotomy in this patient cohort was advised with the assumption that peak infectivity of the virus occurred at 7-10 days following the onset of symptoms such that performing the tracheotomy at that time would produce maximal risk to surgeons performing these procedures 20 .

The P/F ratio, as utilized in our study cohort, has been previously described to designate the severity of acute respiratory distress syndrome (ARDS) 21 (P/F between 200 and 300), moderate (P/F between 100 and 199), and severe (P/F less than 100). These categories were validated in 4188 ARDS patients that demonstrated an in-hospital mortality of 45% for severe ARDS, 32% for moderate ARDS, and 27% for mild ARDS. Delaying tracheotomy until the P/F was greater than 100 in our patient cohort was performed to further assess the short-term prognosis of these patients and to select those COVID-19 patients whose prognosis might be better, thereby justifying the performance of the tracheotomy procedure in these patients.

Heyd et al 17 Finally, increased team member safety during the performance of tracheotomies in COVID-19 patients is at least theoretically possible when these patients have been treated pharmacologically. As noted in our cohort, 3 agents, remdesivir, convalescent plasma, and dexamethasone, have been recommended for use in these patients 35, 36 . Remdesivir, a monophosphate prodrug that is metabolized to a biologically active C-adenosine nucleoside triphosphate analogue, was originally discovered during an antimicrobial assessment of drugs against RNA viruses including Coronaviridae and Flaviviridae 36 . The initial clinical use of remdesivir was in the setting of Ebola, but its use in COVID-19 is at least theoretically indicated based on case report data 31 The limitations of this study include the low number of patients and the inability to determine team member safety related to the procedure. In terms of team member safety, it is not possible to trace transmission of disease to team members from specific contacts, including patients who underwent tracheotomy in this study. While 4 residents participating in the care of these patients became COVID-19 positive at variable times following the tracheotomy procedures, the primary surgeon repeatedly tested negative for COVID-19 and was vaccinated in January 2021. Contact tracing for the positive residents could therefore not definitively establish transmission from a patient in this study, or another COVID-19 patient, unrelated to this study, for whom the residents cared during the study period. Finally, the sample size for the present study was relatively small (n = 17) and larger studies might be able yield more precise and accurate effects associated with tracheotomies in COVID-19 patients. Causal inferences cannot be made from the current study due to the lack of randomization. Future researchers may want to use the effect sizes generated from our study to power larger retrospective studies to permit further investigation regarding the association of tracheotomies and COVID-19 survival, especially as it relates to clinical parameters such as BMI and comorbid disease history. We anticipate larger numbers of tracheotomies in COVID-19 patients in the future with the ability to ascertain durable benefit to these patients who experience prolonged intubation. Moreover, we plan to perform a follow-up study of the 10 surviving tracheotomy patients in this study to determine any future adverse sequelae of their disease such as pulmonary fibrosis and cognitive dysfunction.

Tracheotomies performed in COVID-19 patients are safe and medically beneficial procedures for patients when performed with a standardized protocol such as that discussed in this study. The exact timing of this surgical procedure remains speculative in the international literature however, we recommend guidelines identical to those of non-COVID-19 patients in which intentions to reduce the incidence of laryngeal stenosis and subglottic stenosis, and limiting medical resources such as ventilators and sedative agents are important. To this end, early consultation might be beneficial to patients, with the exact timing of tracheotomy in COVID-19 patients being based on their ventilator parameters, P/F result, perceived patient prognosis, the existence of patient advanced directives, and family wishes. Not uncommonly, medical center ethics committees are very useful to this end and should be utilized in the decision-making process. Finally, we recommend the inclusion of trainees in the performance of tracheotomies in COVID-19 patients as part of standardized teams and protocols to properly prepare these residents and fellows for their future practices. Radiographic signs of pneumonia exist in these patients, consistent with COVID-19 pneumonia. In addition to the patients' symptoms on presentation, as well as their high ventilator parameters and low P/F, the radiographic findings of these patients should alert the intensive care unit team of the likely need for tracheotomy in the future, particularly as prolonged intubation occurs. Proactive planning should occur accordingly. When the tracheotomy was performed prior to 20 days (blue line) following intubation, 7/10 patients (70%) survived, while when the tracheotomy was performed at 20 days or longer following intubation, 3/7 patients (43%) survived. 

Systematic review of international guidelines for tracheostomy in COVID-19 patients

Clinical features of patients infected with 2019 novel coronavirus in Wuhan

The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) -China

Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19). A review

Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 -COVID-NET, 14 States

the Northwell COVID-19 Research Consortium. Presenting characteristics, comorbidities and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area

Baseline characteristic and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region

Recommendations from the CSO-HNS taskforce on performance of tracheotomy during the COVID-19 pandemic

Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

COVID-19 as the leading cause of death in the United States

Deaths from COVID-19

Understanding and addressing sources of anxiety among health care professionals during the COVID-19 pandemic

Morbidity and mortality associated with tracheotomy procedure in a university medical centre

Early outcomes from early tracheostomy for patients with COVID-19

Tracheotomy in ventilated patients with COVID-19

Tracheostomy protocols during COVID-19 pandemic

Delayed tracheostomy in a patient with prolonged invasive mechanical ventilation due to COVID-19

Systematic review of international guidelines for tracheostomy in COVID-19 patients

Temporal dynamics in viral shedding and transmissibility of COVID-19

Acute respiratory distress syndrome. Advances in diagnosis and treatment

Potential predictors of poor prognosis among critical COVID-19 pneumonia patients requiring tracheal intubation

ARDS definition task force. Acute respiratory distress syndrome: The Berlin definition

What is an aerosol-generating procedure?

Tracheotomy in the SARS-CoV-2 pandemic

Tracheotomy in COVID-19 patients: Optimizing patient selection and identifying prognostic indicators

Challenges of tracheotstomy in COVID-19 patients in a tertiary centre in inner city London

Tracheostomy, ventilator wean, and decannulation in COVID-19 patients

Timing, complications, and safety of tracheotomy in critically ill patients with COVID-19

Surgical considerations for tracheostomy during the COVID-19 pandemic. Lessons learned from the severe acute respiratory syndrome outbreak

Novel percutaneous tracheostomy for critically ill patients with COVID-19

Tracheostomy intervention in intubated COVID positive patients: A survey of current clinical practice among ENT surgeons

Safety and 30-day outcomes of tracheostomy for COVID-19: a prospective observational cohort study

Timing of tracheostomy for patients with COVID-19 in the ICU -Setting precedent in unprecedented times

Pharmacologic treatments for coronavirus disease 2019 (COVID-19). A review

Treatment of 5 critically ill patients with COVID-19 with convalescent plasma