ABSTRACT
In the early stages of the pandemic, there were reservations about early tracheostomy due to the high risk of infection transmission. We reported the clinical characteristics and outcomes of patients who underwent an elective tracheostomy during the pandemic.
The data from patients who underwent the elective tracheostomy between March 20, 2020, and January 01, 2021, were evaluated retrospectively. Medical records were analyzed for age, gender, comorbidities, complications, and outcomes. The duration from intubation to tracheostomy and the length of intensive care unit (ICU) and hospital stay were calculated. The data of coronavirus disease-2019 (COVID-19) patients (group I) and non-COVID-19 patients (group II) were compared. Additionally, early tracheostomy (≤14 days) and late tracheostomy (>14 days) groups were compared in terms of clinical outcomes.
A total of 144 patients, 70 of whom were diagnosed with COVID-19, were included. Tracheostomy was performed on the median 19th day in both groups (p=0.85). Percutaneous tracheostomy (68.6%) was performed more frequently in COVID-19 patients. The time of tracheostomy application had no positive effect on mortality in either groups. Bleeding occurred less frequently in group I.
Percutaneous tracheostomy was performed more frequently in COVID-19 patients. Percutaneous tracheostomy is feasible to be conducted by the ICU team at the bedside with few complications.
Keywords: Intensive care unit, tracheostomy, invasive mechanical ventilation, COVID-19
Introduction
During the coronavirus disease-2019 (COVID-19) pandemic, the increasing number of patients caused difficulty on the intensive care unit (ICU) processes (1). COVID-19 can induce severe respiratory problems that require invasive mechanical ventilation (IMV) hence tracheostomy opening due to prolonged IMV (2).
Tracheostomy is one of the commonly performed procedures during prolonged IMV in critically ill patients. Traditionally, tracheostomy is performed to ease weaning from ventilator support, clearance of secretions, improve patient comfort and mobility (3). Additionally, some studies have reported that early tracheostomy shortens the duration of ICU stay (4). However, it’s important to note that tracheostomy carries potential complications, including bleeding, stoma infection, pneumothorax or pneumomediastinum, and even mortality (5-7). Therefore, when deciding whether to perform a tracheostomy, a careful evaluation of the risks and benefits must be conducted (2). Initially, there was reluctance to perform tracheostomies in COVID-19 patients due to high mortality rates and concerns about the transmission of infection (5,6-8). To address the uncertainties, multiple consensus reports have been published specifically addressing tracheostomy in COVID-19 patients (4,6-9). There is insufficient data to make an evidence-based recommendation regarding the timing of tracheostomy in COVID-19 patients (5-7). Besides, the optimal tracheostomy technique (surgical versus percutaneous) in the COVID-19 patients is unclear (5,6). A high level of consensus has been achieved in guidelines on safety standards such as the use of personal protective equipment (PPE) (hair cover, N95 mask, surgical mask, face shield, gown and gloves) and an apneic approach during tracheostomy (10-12). Despite many of the guidelines on tracheostomy practice, there is limited experience and data on tracheostomy performance (5,6,13,14).
Due to the rapid increase in the number of patients with pneumonia who required intensive care treatment during the pandemic in Turkey, existing intensive care beds and even some operating rooms have been converted to ICUs for the treatment of COVID-19 patients. In addition, while anesthesiologists and intensive care specialists were mostly responsible for COVID-19 ICUs, other physicians were assigned to non-COVID-19 ICUs. All these non-routine practices are also likely to cause differences in standard intensive care procedures.
This study had two aims: to compare the clinical features and outcomes of patients with and without COVID-19 who underwent elective tracheostomy; and to evaluate whether the COVID-19 pandemic changed the approach of intensive care specialists to the practice of tracheostomy, which is frequently applied in ICU.
Materials and Methods
Study Design and Patients
This study was approved by the University of Health Sciences Turkey, Bursa City Hospital Clinical Research Ethics Committee (decision no: 2021-1/17, date: 06.01.2021). This retrospective, observational study was conducted in COVID-19 and non-COVID-19 ICUs. The data from patients treated between March 20, 2020, to January 01, 2021, were evaluated. Adult patients (>18 years) who underwent elective tracheostomy were included. The diagnosis of COVID-19 followed the interim guidance provided by the World Health Organization (15).
Data Collection
The demographic and clinical data were obtained from the electronic medical records. Medical records were analyzed for age, gender, comorbidities, laboratory tests, Acute Physiology and Chronic Health Evaluation (APACHE)-II scores, complications due to tracheostomy, and outcomes. The following information was recorded and analyzed: the duration in days from the start of IMV to tracheostomy, from tracheostomy to successful weaning, from tracheostomy to discharge from the ICU, the length of stay (LOS) in the ICU, and the length of hospital stay. Additionally, data regarding the tracheostomy technique (surgical or percutaneous) and potential transmission to healthcare workers were also documented.
Outcomes
The primary outcome was the 28-day survival (from the date of ICU admission). We also determined the 60-day mortality. The secondary outcome measures were tracheostomy technique, ICU stay, discharge from ICU, tracheostomy decannulation rate, and complications.
Exploratory Analyses
We divided the patients who underwent elective tracheostomy into two groups: patients diagnosed with COVID-19 (group I) and those who were not diagnosed with COVID-19 (group II). These groups were compared in terms of demographic, clinical, and outcome data.
Additionally, both groups were divided into two subgroups according to the timing of tracheostomy. There was no difference between the groups in terms of age, gender, APACHE-II values and indication. The study population was divided into two groups: the early tracheostomy group, consisting of patients who underwent tracheostomy within the first 14 days of initiating IMV, and the late tracheostomy group, comprising patients who underwent tracheostomy after 14 days of IMV. Laboratory data at the time of admission to ICU for patients with a diagnosis of COVID-19 were compared for the early and late tracheostomy groups.
Tracheostomy Technique and Procedure
The decision regarding the performance of tracheostomy was made by the intensive care specialist who was responsible for the patients’ care. Furthermore, percutaneous tracheostomies were carried out by the intensive care specialist at the bedside. Our ICU is in the form of single rooms, and the number of personnel inside was limited to three during the procedure. Percutaneous tracheostomy was performed using Griggs percutaneous technique, known as the guidewire dilating forceps technique (16). All surgical tracheostomies were performed by an otolaryngologist and because of viral load and risk to the healthcare team, it was decided to perform a tracheostomy for all patients, specifically after at least 21 days of ventilation and at least one negative reverse transcription-polymerase chain reaction (RT-PCR) test. There was a minimum of five personnel in the negative pressure operating room during the procedure. The surgical technique was performed with a horizontal incision between the 2nd and 3rd rings of the trachea (16). All patients were completely paralyzed by a muscle relaxant. In both techniques, all personnel wore full PPE, and all patients received volume/pressure-controlled ventilation of the lungs with a fraction of inspired oxygen (FiO2) of 100% during the procedure. The ventilator was paused while the tracheostomy cannula was inserted.
Statistical Analysis
The data were analyzed with the statistical software IBM SPSS Statistics for Windows version 20.0 (IBM Corp., Armonk, New York, USA). The descriptive statistics were presented as number (n), percentage (%), mean ± standard deviation, median, and interquartile range values. The normal distribution of the data of the numerical variables was evaluated using the Shapiro-Wilk normality test. Comparisons between groups were performed using Student’s t-test for variables with normal distribution and Mann-Whitney U test for variables not showing normal distribution. The relationship between categorical data was evaluated using chi-square test statistics. A p-value of <0.05 was considered statistically significant.
Results
During the study period, a total of 144 patients, 70 of whom were diagnosed with COVID-19, were included in our study. The mean age of patients diagnosed with COVID-19 (group I) was 68.4 years; 71.4% were male. In group II, the mean age of patients was 67.8 years, and 56.8% were male. Although the groups did not differ significantly by gender and age, the APACHE-II score was significantly higher in group I (p=0.019). Hypertension (44.3%) was the most common comorbidity in group I, while it was cerebrovascular disease (54.1%) in group II. There was no significant difference between the two groups regarding the ICU LOS and duration from tracheostomy to ICU discharge. However, the hospital LOS was significantly shorter in group I (Table 1, 2).
The indication for tracheostomy in all patients was prolonged IMV. The cause of prolonged IMV in group I was pulmonary dysfunction, while it was neuromuscular dysfunction in group II. The median timing of tracheostomy was 19 days after intubation in both groups (range: 1-44 and 1-69 days, respectively). While percutaneous tracheostomy (68.6%) was performed more frequently in group I, surgical tracheostomy (71.6%) was performed more frequently in group II (p<0.001). Early and late tracheostomy rates were similar in the two groups. Early tracheostomy was performed in 17 patients in both groups (p=0.85). The most frequent perioperative complication was bleeding in group II patients as opposed to group I (1.4 vs. 9.5%; p=0.06) (Table 2).
Both groups were divided into two subgroups according to the timing of tracheostomy. There was no difference between the groups in terms of age, gender, APACHE-II values and indication (Table 3). Diabetes mellitus and hypertension were higher in group I. The median duration from intubation to tracheostomy was significantly shorter in the early group (for both of them p<0.001). In group I, percutaneous tracheostomy was performed more frequently in the early tracheostomy patients (88.2%, p=0.07). It was observed that early tracheostomy in COVID-19 patients was associated with shorter durations of ICU and hospital stays (p=0.008 for both). There was no difference between the 28th or 60th-day mortality in the groups who underwent early and late tracheostomy patients (Table 3).
Two patients in group I and five patients in group II were decannulated. The discharge data of the patients from the ICU are presented in Table 4.
Discussion
The COVID-19 pandemic caused an unprecedented increase in the number of critically ill patients. Hospitals are overwhelmed, and medical professionals had to make difficult decisions regarding the care of these patients. The reported transmission of infection and high mortality in COVID-19 patients have raised important questions that need to be addressed for making informed decisions regarding tracheostomy. There is no clear timing for tracheostomy in COVID-19 patients. In addition, it is unknown whether percutaneous or surgical tracheostomy is superior to each other or if it is different in terms of the risk of transmission (13,14,16,17).
Different from other studies, we evaluated tracheostomy applications in critically ill patients with COVID-19 and without COVID-19 (5,13,14). The most common indication for tracheostomy in non-COVID-19 patients was neuromuscular dysfunction, while pulmonary dysfunction in COVID-19 patients. Tracheostomy was performed on the median 19th day in both groups. Considering that the tracheostomy was performed mostly due to neuromuscular dysfunction in the non-COVID-19 patients, the average time from intubation to tracheostomy would be expected to be shorter. We think that this situation is caused by the fact that physicians other than the ICU specialist and anesthesiologist were responsible for non-COVID ICUs during the pandemic and that tracheostomy was performed at least on the 21st day after intubation with one negative RT-PCR test result. Insufficient data on the clinical course, the risk of viral transmission in the early stages of the pandemic, and the presence of asymptomatic carriers were also influential in this decision taken by otolaryngologists. Routine negative RT-PCR test before the procedure was not decided by the ICU team in the COVID ICU. Delaying tracheostomy to achieve negative tests is likely to prolong endotracheal ventilation and thus alter the potential benefits of tracheostomy while increasing the risk of complications related to endotracheal intubation. Critical patients can test positive for PCR for several weeks after the onset of symptoms, but it remains uncertain whether a positive PCR test indicates the presence of infectiousness (18,19).
Although the effects of tracheostomy are mostly revealed by retrospective observational studies, the data on the timing in patients with COVID-19 are even more limited (14,20-22). Glibbery et al. (22) demonstrated a significant positive correlation between the duration from intubation to tracheostomy and variables such as the duration of IMV, time from intubation to decannulation, and time from intubation to ICU discharge. In a multicenter study including 153 patients, it was shown that early tracheostomy application (<15 days) was associated with shorter ICU stay, although no difference was found in terms of mortality (23). Especially during the pandemic, shortening the duration of intensive care and hospital stay is critical for managing the patient population that complicates the hospital operation. Although the ICU stay was short in the early tracheostomy group in our study, mortality was very high in this group.
Tracheostomy is a procedure that can be performed with surgical or percutaneous techniques. With the increasing experience over the years, the number of patients who have undergone percutaneous tracheostomy has increased. However, the pandemic has led to debates on the efficacy and safety of percutaneous and surgical tracheostomy techniques (24-26). Bassi et al. (27) reported that if the suggested precautions are strictly followed, percutaneous tracheostomy could be performed with minimal aerosol spread as well as surgical tracheostomy. In a multicenter prospective observational study that included 1890 COVID-19 patients, Martin-Villares et al. (28) reported that most of the procedures were performed at the bedside in ICU and used the surgical technique. It was reported that there were no cases of COVID-19 related to the procedures among healthcare workers in the study. In our study, the majority of tracheostomy procedures in COVID-19 patients were conducted by intensivist using the percutaneous technique at the patient’s bedside. The utilization of bedside percutaneous tracheostomy has effectively minimized the need for transporting ventilated patients and the associated risks of repeated disconnection and reconnection of ventilator circuits during transportation. In addition, the number of personnel could be kept more limited with the percutaneous tracheostomy compared to the surgical tracheostomy (three versus a minimum of five staff, respectively). Unlike the period before the pandemic, in both percutaneous and open techniques, ventilation was stopped from the time of opening the trachea to placing the tracheostomy tube and inflating the cuff, and the whole team used the appropriate PPE. Although we did not have a strict protocol on the timing or method for tracheostomy, we had a standard approach, and all precautions were consistently taken to minimize risks to clinicians. No transmissions to healthcare workers occurred during any procedure.
The most frequently reported complication associated with a tracheostomy procedure is minor bleeding (28). The most common complication in our study was also bleeding. Surgical tracheostomy was performed in five of the eight patients who developed bleeding (one patient in group I, four patients in group II). None of the patients required blood transfusion or surgical procedures related to tracheostomy bleeding. It has been reported that the use of a smaller incision and blunt dissection are associated with less bleeding in percutaneous tracheostomy. Also, the stoma fits tightly around the tracheostomy tube and is effective in reducing bleeding with its compression effect (24-26).
This study is one of the first and largest series to describe early outcomes of COVID-19 patients undergoing tracheostomy in Turkey. In addition, according to our research, it is the first study in the literature to compare tracheostomy applications in COVID-19 and non-COVID-19 patients during the pandemic period. However, our study has several limitations. This is a retrospective cohort study with a relatively small number of patients and short-term mortality. Therefore, the power to detect mortality differences may be inadequate. The analysis of long-term outcomes, long-term disability, and chronic care were also lacking. Comparing patients according to the diagnosis of COVID-19 is one of the strengths of our study.
Conclusion
The impact of tracheostomy procedures on the clinical outcomes of COVID-19 patients remains uncertain, and there is currently no definitive indication regarding the timing of tracheostomy in these patients. There is a need for studies that will guide the timing of tracheostomy and the effect of tracheostomy techniques on morbidity and mortality in critically ill, mechanically ventilated COVID-19 patients.
This study shows that percutaneous tracheostomy can be performed by the ICU physician at the bedside with few complications. Since percutaneous tracheostomy can be applied safely at the bedside, it seems more advantageous than surgical tracheostomy, as there is no need for patient transport, and the number of personnel can be kept more limited during the procedure. However, the timing and type of tracheostomy did not affect survival.
Ethics
Ethics Committee Approval: Ethics approval was received from the University of Health Sciences Turkey, Bursa City Hospital Clinical Research Ethics Committee on January 6, 2021, with the decision number 2021-1/17.
Informed Consent: Retrospective study.
Peer-review: Externally peer-reviewed.
Authorship Contributions
Surgical and Medical Practices: G.Ç., S.T., P.K.K., G.T., Concept: G.Ç., P.K.K., E.U., N.K.G., Design: G.Ç., S.T., G.T., N.K.G., Data Collection and Process: S.T., P.K.K., G.T., E.U., Analysis or Interpretation: G.Ç., P.K.K., N.K.G., Literature Search: S.T., G.T., E.U., Writing: G.Ç., N.K.G.
Conflict of Interest: No conflict of interest was declared by the authors.
Financial Disclosure: The authors declared that this study received no financial support.
