Early Percutaneous Tracheostomy in Coronavirus Disease 2019: Association With Hospital Mortality and Factors Associated With Removal of Tracheostomy Tube at ICU Discharge. A Cohort Study on 121 Patients* : Critical Care Medicine

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Early Percutaneous Tracheostomy in Coronavirus Disease 2019: Association With Hospital Mortality and Factors Associated With Removal of Tracheostomy Tube at ICU Discharge. A Cohort Study on 121 Patients*

Rosano, Antonio MD; Martinelli, Enrico MD; Fusina, Federica MD; Albani, Filippo MD; Caserta, Rosalba MD; Morandi, Alessandro MD; Dell’Agnolo, Piera MD; Dicembrini, Alessandra MD; Mansouri, Leila MD; Marchini, Andrea MD; Schivalocchi, Valeria MD; Natalini, Giuseppe MD

Author Information
Critical Care Medicine 49(2):p 261-270, February 2021. | DOI: 10.1097/CCM.0000000000004752
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  • COVID-19


Tracheotomy is commonly performed in critically ill patients needing prolonged mechanical ventilation after an initial period of translaryngeal intubation, with a prevalence of approximately 13% in patients with acute respiratory distress syndrome (ARDS) (1).

Early tracheotomy, defined as a procedure performed within 10 days from translaryngeal intubation, is associated with a significantly higher rate of tracheotomy but a larger number of ventilator free days, shorter ICU stays, shorter duration of sedation, and lower long-term mortality rates than late tracheotomy (2). In particular, percutaneous tracheostomy appears to be more cost-effective since it releases operating room resources and provides greater feasibility in terms of bedside capability than surgical tracheostomy (3).

A shorter ICU stay and the opportunity to save operating room resources were particularly valuable during the coronavirus disease 2019 (COVID-19) pandemic, when ICUs had insufficient beds, and operating rooms were occupied as additional ICU stations. In this context of limited resources, early percutaneous tracheostomy could be an effective way to manage mechanically ventilated patients. Nevertheless, current recommendations in COVID-19 suggest delaying the tracheotomy beyond the 10th to 14th day of mechanical ventilation if patients show signs of clinical improvement or to consider extended translaryngeal intubation as the standard of care for the entire duration of ventilation and to perform tracheotomy only when patients become negative to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) tests (4,5).

From February 20, 2020, to April 30, 2020, more than 2,000 patients with confirmed COVID-19 were referred to our hospital located in the epicenter of the SARS-CoV-2 pandemic in Italy. In the absence of definitive evidence about the risk of tracheotomy for the involved operators (6), we decided to perform early percutaneous tracheostomy in all mechanically ventilated patients, so as to improve outcome and optimize the use of the available resources.

Aim of the study was to analyze the hospital mortality of COVID-19 patients who had received early percutaneous tracheostomy and factors affecting weaning from the tracheostomy tube at ICU discharge.


This study protocol was approved by the Ethical Committee of Brescia. We analyzed patients admitted between February 20, 2020, and May 10, 2020, to Fondazione Poliambulanza, a tertiary referral hospital with 600 beds located in Brescia (Lombardy, Italy).

Patients were included in the study if they had a positive real-time polymerase chain reaction (RT-PCR) test for SARS-CoV 2 from a biological sample and required ICU admission and invasive mechanical ventilation for severe pneumonia.

Patients were excluded from the analysis if they died or were discharged alive within the first 3 days since ICU admission, because during this period, they were not taken in consideration for tracheostomy (see below).

Demographic and clinical data were extracted from the electronic medical records.

Sequential Organ Failure Assessment (SOFA) (7) score during the first 24 hours and Simplified Acute Physiology Score II (8) were calculated.

Corrected minute ventilation was calculated as a surrogate measure of dead space as (tidal volume respiratory rate Paco2)/40 mm Hg, where tidal volume is expressed in liters and 40 mm Hg is considered the physiologic value of Paco2 (9).

The patients’ sedation level during ICU stay was assessed with the Richmond Agitation-Sedation Scale and delirium with the confusion assessment method for the ICU (10).

Weaning From Mechanical Ventilation and Tracheostomy

Assisted ventilation was begun if Pao2/Fio2 was greater than 100 mm Hg with positive end-expiratory pressure (PEEP) lower than 15 cm H2O. Assisted ventilation was performed with pressure support ventilation or assist pressure controlled ventilation. In selected patients, airway pressure-release ventilation was used for 1–2 days as a bridge between controlled and assisted ventilations. Patients were assessed every day to evaluate if they were ready to wean (10). If so, they underwent a 60-minute spontaneous breathing trial with pressure support ventilation, setting 5 cm H2O of inspiratory support and 5 cm H2O of PEEP (11). Patients were extubated if they passed the respiratory breathing trial (12). We accepted a Pao2/Fio2 higher than 100 mm Hg at the end of the spontaneous breathing trial as sufficient for extubation in the presence of comfortable breathing pattern and if dyspnea was absent.

Patients were evaluated for percutaneous tracheostomy after the first 3 days of mechanical ventilation, if weaning from mechanical ventilation could not be reasonably completed within the next 7 days. Tracheotomy was not considered during the first 3 days from translaryngeal intubation. Tracheostomy was performed between the 4th and the 10th day from translaryngeal intubation if extubation could not be reasonably obtained in this period. Patients were not considered for tracheotomy only if they were judged as moribund by the attending physician. The need for a prone position required postponing the tracheostomy to the time in which pronation was no longer required.

All tracheotomies were performed at the bedside with a percutaneous single-dilator technique and guided by tracheal fiberoscopy. Ventilation was never stopped during the procedure.

Removal of Tracheostomy Tube/Tracheostomy Closure

In our ICU, a protocol to assess if tracheostomy tube could be safely removed and tracheostomy closed has been in use since 2012. All tracheostomized patients are assessed twice a day for a period of spontaneous breathing through a T-piece. Spontaneous breathing is terminated and mechanical ventilation resumed if signs of respiratory distress occur (12). After 24 hours of spontaneous breathing, conscious patients are evaluated to rule out the presence of dysphagia with a two-step protocol. In the first step, the cuff of the tracheal cannula is deflated and a sponge used for oral hygiene is soaked in 5 mL of methylene blue. Vestibules, cheeks, and, when possible, hard palate and tongue are colored. The patient is then observed for 24 hours, looking for the presence of blue secretions from the tracheostoma. The second step is performed if no colored oral secretions are recovered from the tracheal cannula during the first step: colored thickened water and semisolid foods are orally administered by mouth, and the tracheostomy tube is checked for secretions in the following 6 hours.

All tracheostomized patients with consistent periods of spontaneous breathing receive rehabilitative treatment two times a day by dedicated physiotherapists. Early mobilization from bed is gradually increased, reaching, if possible, assisted walking. Swallow is regularly assessed and swallowing exercises are performed by a skilled Speech and Language therapist. Usually this approach is started early in all ICU patients, but during the COVID-19 pandemia, we had to start it when patients approached liberation from mechanical ventilation, due to the excessive number of mechanically ventilated patients in ICU.

The tracheostomy tube was removed after 3 consecutive days without the need of ventilatory support in nondysphagic patients (those who had succeeded at least at the first step of the above described protocol), if tracheal aspiration was not frequently required and if cough was sufficient to expectorate the tracheal secretions out of the tracheostomy tube. The stoma was covered with a medication and left to heal by second intention.

Oral feeding was allowed if patients did not show dysphagia at the second step of the protocol.

If the tracheostomy tube could not be removed before the discharge from ICU, it was substituted by a tracheostomy tube with a removable inner cannula, and then, patients were transferred to a rehabilitation facility.


The primary outcome was to assess if early percutaneous tracheostomy was independently associated with increased hospital mortality, which could be the possible consequence of a harmful or futile procedure. Secondary outcome was to identify the variables associated with survival in tracheostomized patients and those related with removal of the tracheostomy tube/tracheostomy closure at ICU discharge.

Statistical Analysis

We estimated a hospital mortality of 50% in the 180 patients enrolled in the study. We could therefore include up to nine variables in the multivariable analysis (13).

Data are shown as mean (sd), median (1st–3rd quartiles), and frequency (%). Comparison between the variables was performed with t test for numeric normally distributed variables, Wilcoxon-Mann-Whitney test for ordinal and numeric not-normally distributed variables, and Fisher exact test for nominal variables.

The explanatory variables were included in the multiple logistic regression if they reached statistical significance at the bivariate analysis (p < 0.05). Pao2/Fio2 and Paco2 were excluded a priori from multiple analysis, because they were already included in SOFA’s respiratory subscore and used in the calculation of corrected minute ventilation, respectively. Odds ratios and 95% CI were calculated.

The statistical software R (R Foundation for Statistical Computing, Vienna, Austria) was used for analysis.


Tracheostomized Versus Nontracheostomized Patients

During the study period, 181 patients with COVID-19 ARDS were admitted to ICU due to the need for invasive mechanical ventilation and 17 out of them (9 %) were discharged from ICU during the first 3 days from admission (13 patients died and four were discharged alive). The complete flowchart of study patients is shown in Figure 1. Three days after ICU admission, 164 patients were still present in ICU and included in the analysis. The characteristics and outcome of tracheostomized and not tracheostomized patients are compared in Table 1. Tracheotomy was performed on median on the 6th day of intubation, and 118 (98%) were performed in the first 10 days, whereas the latest procedure was done after 12 days (Fig. 2).

TABLE 1. - Characteristics and Outcome of Tracheostomized and Not Tracheostomized Patients
Variables Not Tracheostomized Tracheostomized p Adjusted OR (95% CI; p)
Number of patients 43 (26%) 121 (74%)
Hospital mortality (%) 27 (62.8%) 55 (45.5%) 0.08 0.03 (0.00–0.25; p = 0.01)
Male sex (%) 33 (77%) 28/93 (77%) 1
Age (yr) 65 (11) 65 (9) 0.88
Body mass index (kg/m2) 29 (26–33) 28 (25–31) 0.03 0.88 (0.74–1.00; p = 0.08)
Arterial hypertension 11 (26%) 20 (17%) 0.26
Diabetes mellitus 10 (23%) 9 (7%) 0.01 0.05 (0.00–0.48; p = 0.02)
Respiratory SOFA 3 (3–3) 3 (3–3) 0.14
Coagulation SOFA 0 (0–0) 0 (0–0) 0.10
Liver SOFA 0 (0–1) 0 (0–0) 0.16
Cardiovascular SOFA 1(1–1) 1 (0–1) 0.42
Neurological SOFA 2 (2–2) 2 (2–2) 0.008 0.70 (0.12–3.85; p = 0.66)
Renal SOFA 1 (0–3) 0 (0–1) 0.02 0.79 (0.51–1.23; p = 0.30)
SOFA 8 (6–10) 6 (6–8) 0.22
Controlled mechanical ventilation 30 (71%) 83 (73%) 0.84
Positive end-expiratory pressure 11 (4) 10 (4) 0.24
Driving pressure 13 (4) 12 (4) 0.10
Compliance 27 (22–34) 36 (27–41) 0.013 1.04 (0.98–1.12; p = 0.26)
Pao 2/Fio 2 150.00 (105–188) 145.00 (116–178) 0.98
Tidal volume/ideal body weight (mL/kg) 6.05 (5.30–7.75) 6.10 (5.60–6.70) 0.81
Paco 2 57 (17) 57 (15) 0.99
Corrected minute ventilation 13.24 (11.83–17.25) 13.50 (11.13–15.57) 0.79
OR = odds ratio, SOFA = Sequential Organ Failure Assessment.
Data are referred to the day of entry in the study, i.e., third day from ICU admission.
Data are shown as mean (sd), median (1st–3rd quartile), count (%). p ≤ 0.05 was considered statistically significant.

Figure 1.:
Flowchart of study patients.
Figure 2.:
Distribution of tracheotomy on each day of ICU stay.

One-hundred and twenty-one patients (74%) were tracheostomized, whereas the other 43 (26%) were managed only with translaryngeal intubation. Twenty out of 181 enrolled patients (11%) were successfully extubated after 4 days (2.75–5.25 d) of intubation. None of these patients required reintubation and all were discharged alive from ICU. In multivariable analysis, early percutaneous tracheostomy was associated with a lower hospital mortality and prevalence of diabetes mellitus.

Tracheostomized Patients

Sixty-six of tracheostomized patients (55%) were discharged alive from the hospital (Table 2). Age and male sex were the only characteristics that were independently associated with mortality in the tracheotomized patients.

TABLE 2. - Comparison Between Survivors and Nonsurvivors in Tracheostomized Patients
Variables Survivors Nonsurvivors p Adjusted OR (95% CI; p)
Number 66 (55%) 55 (45%)
Male sex 44 (67%) 49 (89%) 0.005 5.48 (1.92–18.5; p = 0.003)
Age (yr) 63 (9) 67 (7) 0.005 1.07 (1.02–1.13; p = 0.005)
Body mass index (kg/m2) 28 (25–30) 27 (26–31) 0.83
Arterial hypertension 11 (16.7%) 9 (16.4%) 1
Diabetes mellitus 4 (6.1%) 5 (9.1%) 0.73
Respiratory SOFAa 3 (3–3) 3 (3–3) 0.14
Coagulation SOFAa 0 (0–0) 0 (0–0) 0.04 1.33 (0.65–2.91; p = 0.44)
Liver SOFAa 0 (0–0) 0 (0–0) 0.99
Cardiovascular SOFAa 1 (0–1) 1 (0–1) 0.65
Neurological SOFAa 2 (2–2) 2 (2–2) 0.95
Renal SOFAa 0 (0–1) 1 (0–1) 0.09
SOFAa 6 (6–7) 7 (6–8) 0.08
Pao 2/Fio 2b 135 (117–184) 130 (107–152) 0.11
pHb 7.16 (0.37) 7.17 (0.38) 0.81
Paco 2b (mm Hg) 50 (44–62) 54 (44–68) 0.51
Vasoactive agentsb 16 (25%) 22 (40%) 0.15
Paralysisb 30 (52%) 16 (35%) 0.11
Sedationb 48 (83%) 32 (70%) 0.16
OR = odds ratio, SOFA = Sequential Organ Failure Assessment.
aData refer to third day from ICU admission.
bData refer to day on which tracheotomy was performed.
Data are shown as mean (sd), median (1st–3rd quartile), and count (%). p ≤ 0.05 was considered statistically significant.

Weaning from tracheotomy tube was obtained in 47 of tracheotomized patients (71%) who were discharged alive (see Fig. 1). None of the patients in whom the tracheostomy tube was removed following the protocol presented in the methods had to be subsequently reintubated or had to have the tracheostomy tube repositioned.

Tracheostomized Patients Discharged Alive From Hospital

Table 3 compares the characteristics of the tracheostomized patients discharged alive who removed or did not remove the tracheostomy tube before ICU discharge. Patients who removed the tracheostomy tube before ICU discharge maintained it for 18 days (11.5–24 d) after tracheotomy and were discharged from ICU 1 day (1–2 d) after the removal of the tracheostomy tube. Patients who were discharged from ICU with the tracheostomy tube had a length of stay with a tracheostomy of 35 days [26.5–40 d]. The only variable independently associated with tracheostomy tube removal at ICU discharge was a faster recovery of spontaneous breathing after tracheotomy was performed.

TABLE 3. - Comparison of Characteristics of Patients Who Removed and Did Not Remove the Tracheostomy Tube at ICU Discharge
Variables Patients Who Did Not Remove the Tracheostomy Tube Patients Who Removed the Tracheostomy Tube p Adjusted OR (95% CI; p)
Number 19 47
Male sex 13 (68) 31 (66) 1
Age (yr) 64 (9) 62 (9) 0.56
Body mass index (kg/m2) 26 (24–29) 28 (26–31) 0.04 1.11 (0.95–1.39; p = 0.27)
Arterial hypertension 1 (5%) 10 (21%) 0.16
Diabetes mellitus 2 (11%) 2 (4%) 0.57
Day of tracheotomy from ICU admission 7 (6–8) 6 (6–7) 0.26
Day on which spontaneous breathing started after tracheotomy 10 (6–16) 6 (2–10) 0.02 0.87 (0.75–1.00; p = 0.05)
Length of stay in ICU with tracheostomy tube 35 (27–40) 18 (12–24) < 0.001
Length of stay in ICU after removal of tracheostomy tube 1 (1–2)
Number of mobilized patients 11 (61%) 31 (71%) 0.55
Glasgow Coma Scale motor score 6 (6–6) 6 (6–6) 0.03 5.66 (1.2–187; p = 0.19)
Richmond Agitation-Sedation Scale 0 (0–0) 0 (0–0) 0.13
Delirium 7 (39%) 12 (27%) 0.38
Pao 2/Fio 2 257 (86) 257 (70) 0.10
OR = odds ratio.
Data are shown as mean (sd), median (1st–3rd quartile), and count (%). p ≤ 0.05 was considered statistically significant.


Early percutaneous tracheostomy in patients with COVID-19 was an efficient management strategy when considered after the first 3 days of mechanical ventilation: most tracheostomized patients survived and most of the survivors were discharged from ICU after the removal of the tracheostomy tube.

The Effect of the Early Approach to Percutaneous Tracheostomy

There are few published data on percutaneous and surgical tracheostomy in COVID-19 patients, and outcome analysis are lacking (14,15). A U.K. unpublished register of tracheostomy in COVID-19 patients, which was not certified by peer review, reports 563 procedures, 217 of them performed with percutaneous techniques (16). Nevertheless, all these reports included late tracheotomy, with a median time of translaryngeal intubation longer than 2 weeks. Therefore, a main peculiarity of our data is the specificity of approach, including only early and percutaneous tracheostomy. Early percutaneous tracheostomy was independently associated with decreased hospital mortality. This finding does not imply a cause-effect relationship and does not demonstrate that early percutaneous tracheostomy reduced mortality by itself. Nevertheless, the favorable association between tracheostomy and hospital survival revealed that early percutaneous tracheostomy did not result in futile procedures and that it assured a good chance of survival. There are several favorable effects of the tracheostomy. Replacing the translaryngeal with the tracheostomy tube favors a lower frequency of oral lesions and better oral hygiene (17); moreover, early tracheostomy shortens the duration of sedation (18) and ICU stay, increases the number of ventilator free days, and reduces long-term mortality compared with late tracheostomy (2).

Tracheostomy reduces the work of breathing (19,20), improves the values of weaning parameters (21), can facilitate the weaning process, and reduce unplanned or failed extubations (22).

In our patients, the choice of the early approach to tracheostomy effectively avoided the problem of failed extubation with its described adverse effects (23,24), such as the need for reintubation and the risk of contagion (6). All our extubated patients (11% of patients with translaryngeal intubation) were discharged from intensive care without the need for mechanical ventilation for the next 72 hours.

Conversely, when tracheotomy is delayed, failed extubation becomes an actual problem, and it turns into one of the indications for tracheostomy, as reported in the U.K. database of tracheostomies (16). In other words, tracheal extubation occurs with maximum safety when an early tracheostomy strategy is implemented

The Safety Issues of Early Percutaneous Tracheostomy in COVID-19

At the beginning of COVID-19 pandemic, guidelines and recommendations advised to avoid or delay it in COVID-19 patients (4,5). In absence of evidence, the rationale against early tracheotomy in COVID-19 ARDS patients is based around concerns of it being an aerosol generating procedure and harmful to caregivers. We collected data on the frequency of SARS-CoV-2 infection in ICU doctors and nurses involved in the 121 early percutaneous tracheotomies analyzed in this study and compared it with the prevalence of SARS-CoV-2 infection in ICU healthcare workers who never participated in tracheotomies. SARS-CoV-2 infection was diagnosed with RT-PCR test from a nasopharyngeal swab or in presence of IgM or IgG for SARS-CoV-2 in the serum. Seven out of 91 doctors and nurses (7.7%) performing the tracheotomies were infected versus 6/52 healthcare workers (11.5%) not involved in any tracheotomy procedure (p = 0.55) (data submitted for publication). Therefore, we excluded that the early approach to the percutaneous tracheotomy used with our patients could be of concern for the safety of the doctors and nurses performing it.

The study results depend on the choice to exclude from analysis patients who were discharged in the first 3 days after ICU admission since we decided to not consider placing a tracheostomy during this time frame. The choice to evaluate patients for tracheostomy only after the first 3 days of mechanical ventilation was arbitrary, but published data support the rationale of this time threshold.

The Removal of the Tracheostomy Tube

The removal of tracheostomy tube/tracheostomy closure is a relevant outcome, allowing a safe discharge of patients to the ward. This was possible in 71% of our patient, a rate similar to the one found in other studies adopting an intensivist-led multidisciplinary approach similar to ours (23–25). In the COVID-19 pandemic, we maintained this multidisciplinary approach despite an increased workload, since the physiotherapist and speech therapist increased their availability due to the drastic reduction of their other elective activities.

Clinicians think that the patient’s level of consciousness, cough effectiveness, secretions, and oxygenation are important determinants of tracheostomy tube removal (26). We agree on the first three items, and therefore, in our protocol, they are prerequisites to consider the removal of the tracheostomy tube, along with the absence of dysphagia. On the contrary, we believe that oxygenation is not an important prerequisite for the removal of the tracheostomy tube provided that all the other conditions are met. This is confirmed by the fact that Pao2/Fio2 was similar between the patients who removed or did not remove the tracheostomy tube at ICU discharge, being the ability to start early spontaneous breathing, the only characteristic independently associated with tracheostomy tube removal.

Study Limitations

The study results depend on the choice to exclude from analysis patients who were discharged in the first 3 days after ICU admission since we decided to not consider placing a tracheostomy during this time frame. The choice to evaluate patients for tracheostomy only after the first 3 days of mechanical ventilation was arbitrary, but published data support the rationale of this time threshold.

Moreover, data shown in our study represent the experience of a single center and, therefore, should be considered cautiously when applied to other settings. Finally, these results cannot be extended to non-COVID-19 patients in the absence of further evidence: they should be considered as the result of a pandemic and of an exceptional context, characterized by unrepeatable organizational, environmental, and ethical singularities.


In conclusion, early percutaneous tracheostomy was safe and effective in COVID-19 patients, since it was not associated with increased mortality and it gave a good chance of tracheostomy tube removal at ICU discharge. Further studies need to confirm these results in different settings and in patients with different diseases.


The authors thank the clinical staff who treated the patients in Poliambulanza Foundation Hospital.


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COVID-19; SARS-CoV-2; tracheostomy; tracheotomy; viral pneumonia

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