ABSTRACT
Background:
Patients with coronavirus disease 2019 (COVID-19) pneumonitis may progress to acute respiratory distress syndrome (ARDS) requiring endotracheal intubation and prolonged mechanical ventilation (MV). There are limited data on the optimum time of tracheostomy in COVID-19 patients progressing to ARDS.
Methods:
This was a retrospective observational study of all patients diagnosed with COVID-19 who progressed to ARDS requiring MV and undergone tracheostomy. We aimed to conduct a study to observe the impact of tracheostomy on the mortality of these patients and the impact of timing of tracheostomy on outcomes in these patients.
Results:
Of the total 162 patients, 128 (79%) were male and 34 (21%) were female. Early group (≤14 days) comprised 37 patients, while 125 patients were included in late group (>14 days). A total of 91 (56%) patients died at the end of this period. Among the patients who died, 21were included in the early group, while the late group comprised the remaining 70 patients. On comparing the patients who died, the duration of stay in the intensive care unit (ICU) was significantly different in the two groups (median [Q1–Q3]: 12 [11–13] vs. 23 [19–28] days, P < 0.001). The number of days to death also differed significantly between the two groups (median [Q1–Q3]: 28 [21–38] vs. 24 [14–30] days, P = 0.009).
Conclusion:
Early tracheostomy is associated with significantly shorter length of ICU stay in COVID-19 patients that have progressed to ARDS. However, the timing of tracheostomy had no influence on the overall mortality rate in these patients.
Keywords: Acute respiratory distress syndrome, coronavirus disease 2019, tracheostomy
INTRODUCTION
The coronavirus disease 2019 (COVID-19) is a contagious infection caused by the severe acute respiratory syndrome coronavirus 2. A majority of the patients with COVID-19 experience only mild symptoms.[1] Although the percentage is small, the absolute number of patients who are critically ill and require invasive mechanical ventilation (MV) and prolonged intensive care unit (ICU) stays have been reported to be large, owing to the pandemic nature of the disease.[1] Patients with COVID-19 pneumonitis may progress to acute respiratory distress syndrome (ARDS) requiring endotracheal intubation and prolonged MV.
Whether to perform tracheostomy in patients requiring prolonged MV is a debatable question. Studies have shown that tracheostomy may prove to be beneficial as compared to prolonged translaryngeal intubation.[2,3,4,5,6,7] These benefits include a reduced risk of injury to the larynx, facilitated MV weaning, and improved patient comfort.[2,3,4,5,6,7] In addition, it may lead to a reduced need for sedatives, which further improves the weaning shortening the ICU and hospital stay.[5] However, tracheostomies may lead to few rare complications such as stomal hemorrhage, tracheostenosis, pneumomediastinum, and stomal infection.[4,8,9,10,11,12] Nevertheless, the number of patients undergoing tracheostomies for prolonged MV is on the rise.[13] A study by Combes et al. demonstrated that tracheostomy performed in the ICU for prolonged MV reduced the ICU and overall in-hospital mortality rate.[14]
The type (surgical vs. percutaneous) and timing (early [variously described as <7, 10 or 14 days after tracheal intubation] vs. late [variously described as >7, 10, 14 days after tracheal intubation]) of tracheostomy are some of the factors that need to be taken into consideration. The optimal timing of tracheostomy in ICU patients is controversial with multiple guidelines giving contrasting recommendations. The early guidelines were designed to advice against tracheostomy due to the increased risk of infection in health-care workers from aerosol generation and exposure. A systematic review in non-COVID-19 patients by Andriolo et al. concluded that with regard to the mortality, seven studies showed a significantly higher mortality rate in the early group (described as <10 days) as compared to the late group (>10 days).[6,15,16,17,18,19,20,21] Another systematic review conducted on non-COVID-19 patients by Liu et al., in 2014, concluded that an early (<7 days) tracheostomy was associated with a reduced stay in the ICU and there was no significant difference in the mortality between the two groups.[22]
There are limited data on the optimum time of tracheostomy in COVID-19 patients progressing to ARDS. A review by Chong and Tan suggested that early (described in included studies as < 10 or 14 days) tracheostomy reduced the ICU stay in patients with coronavirus disease, but did not decrease mortality.[23] Contrary to this, evidence exists that early (<14 days) tracheostomy is associated with a higher mortality rate.[24]
Thus, we aimed to conduct a study to observe the impact of tracheostomy on the mortality of patients with COVID-19 ARDS. We also aimed to assess the impact of timing of tracheostomy on outcomes in these patients who were on MV. Studies assessing the influence of timing of tracheostomy on the length of ICU stay and overall mortality are limited in our setting.
METHODS
We conducted a retrospective observational study. We included all the patients diagnosed with COVID-19 that had progressed to ARDS requiring MV and had undergone tracheostomy from June 1, 2020, to November 30, 2022, at a tertiary care hospital [Figure 1]. We excluded patients who had undergone tracheostomy prior to their hospitalization. The study was commenced only after an institutional ethical committee approval was granted. Consent from the participants was waived due to the retrospective nature of the study.
Figure 1.
Flowchart of patient enrolment. COVID-19: Coronavirus disease 2019, ICU: Intensive care unit
Definitions
Early and late tracheostomy: Patients were classified in to two groups; the early group (≤14 days) and the late group (>14 days) depending on the timing of tracheostomy from the onset of MV.
Time to tracheostomy: the time elapsed from endotracheal intubation to when tracheostomy is performed.
Length of ICU stay (ICU LOS): the time between admission to the ICU to discharge from the ICU.
All patients were under the care of intensivists in the ICU and underwent bedside percutaneous tracheostomy. Single tapered dilator technique under bronchoscopic guidance and prior assessment with ultrasonography was the technique used for performing percutaneous tracheostomy, as previously described by us.[25] Demographics, ventilator settings, and outcomes (mortality, ICU LOS, length of hospital stay [Hospital LOS], use of inotropes, and renal replacement therapy) were monitored.
Statistical analysis
Data were summarized as medians (interquartile ranges) for continuous variables and as frequencies (percentages) for categorical variables. Evaluation of the association between continuous variables was done using the Wilcoxon rank–sum test and for categorical variables, using Fisher’s exact test. Univariable and multivariable logistic regression analyses were used to evaluate estimate the odds of the death occurring given several potentially explanatory variables. Odds ratios with their 95% confidence intervals were reported.
P < 0.05 was considered statistically significant in the entire study. All hypotheses were formulated using two-tailed alternatives against each null hypothesis. The data were analyzed using R, version 4.2.3 (R Project for Statistical Computing [R core team (2023). R Foundation for statistical computing, Vienna, Austria. <https://www.R-project.org/>]).
RESULTS
A total of 162 patients were included in the analysis. Of the 162 patients, 128 (79%) were male and 34 (21%) were female. The early group (≤14 days) comprised 37 patients, whereas 125 patients were included in the late group (>14 days).
Table 1 shows the detailed demographic characteristics, coexisting illnesses and medications, laboratory values, and interventions performed on all the participants in the study.
Table 1.
Baseline demographic variables, coexisting illnesses, laboratory values, and interventions in tracheostomized patients
| Variable | Total (n=162) | Early (≤14 days) (n=37) | Late (>14 days) (n=125) | P |
|---|---|---|---|---|
| Age (years), median (IQR) | 57 (48–66) | 55 (47–65) | 57 (48–66) | 0.87 |
| Sex, n (%) | ||||
| Male | 128 (79.01) | 28 (76) | 100 (80) | 0.57 |
| Female | 34 (20.99) | 9 (24) | 25 (20) | |
| BMI (kg/m2), mean | 29.9 | 29 | 32 | 0.056 |
| SAPS3 | 56 (46–80) | 66 (44–76) | 53 (47–81) | 0.96 |
| Co-existing illness, n (%) | ||||
| CAD/HF | 77 (48) | 18 (49) | 59 (47) | 0.88 |
| Obesity | 98 (60) | 24 (65) | 74 (59) | 0.54 |
| HTN | 89 (55) | 21 (57) | 68 (54) | 0.80 |
| COPD | 33 (20) | 8 (22) | 25 (20) | 0.83 |
| DM | 86 (53) | 20 (54) | 66 (53) | 0.89 |
| COVID-19 medication, n (%) | ||||
| No | 56 (35) | 16 (43) | 40 (32) | 0.21 |
| Remdesivir | 80 (49) | 18 (49) | 62 (50) | 0.92 |
| Tocilizumab | 33 (20) | 10 (27) | 23 (18) | 0.25 |
| Laboratory upon admission, median (IQR) | ||||
| WBC (103/µL) | 9.00 (5.9–10.30) | 9.1 (7.0–10.10) | 8.90 (6.70–10.70) | 0.11 |
| AST (IU) | 49 (39–62) | 48 (38–63) | 51 (42–62) | 0.10 |
| ALT (IU) | 29 (19–37) | 31 (22–39) | 28 (17–37) | 0.14 |
| LDH (IU) | 402 (314–521) | 350 (302–499) | 425 (329–526) | 0.060 |
| CRP (mg/L) | 164 (141–187) | 168 (146–189) | 162 (140–184) | 0.058 |
| Interventions on MV, n (%) | ||||
| Prone | 96 (59) | 25 (68) | 71 (57) | 0.24 |
| Dialysis | 77 (48) | 19 (51) | 58 (46) | 0.60 |
| Time to intubation from hospital admission (days), median (IQR) | 5.7 (3–7) | 5.2 (3–6) | 6.0 (3–7) | 0.072 |
| Time to tracheostomy from intubation (days), median (IQR) | 22.74 (15–26) | 11.92 (11–13) | 26.46 (18–30) | <0.0001 |
IQR: Interquartile range, BMI: Body mass index, SAPS3: Simplified acute physiology score, CAD/HF: Coronary artery disease/heart failure, HTN: Hypertension, COPD: Chronic obstructive pulmonary disease, DM: Diabetes mellitus, WBC: White blood cell, AST: Aspartate aminotransferase, ALT: Alanine aminotransferase, LDH: Lactate dehydrogenase, CRP: C-reactive protein, MV: Mechanical ventilation, COVID-19: Coronavirus disease 2019
Table 2 shows the outcomes of the patients included at 60 days if ICU admission. Of the 162 patients, 64 (40%) were weaned off the ventilator. A total of 91 (56%) patients died at the end of this period. Among the patients who died, 21were included in the early group, while the late group comprised the remaining 70 patients.
Table 2.
Outcomes of patients at 60 days of intensive care unit admission
| Variable | Total (n=162) | Early (≤14 days) (n=37) | Late (>14 days) (n=125) | P |
|---|---|---|---|---|
| Outcomes | ||||
| Weaned from ventilator, n (%) | 64 (40) | 15 (41) | 49 (39) | 0.88 |
| Days to weaning from ventilator (days) | 24 (18–43) | 28 (19–43) | 24 (17–43) | 0.51 |
| Decannulation, n (%) | 42 (26) | 10 (27) | 32 (26) | 0.52 |
| Days to decannulation from tracheostomy (days) | 13 (9–17) | 13 (8–15) | 13 (10–17) | 0.20 |
| Death, n (%) | 91 (56) | 21 (57) | 70 (56) | 0.94 |
n: Number of patients
Table 3 shows the comparative analysis of all the patients whose outcome was death at the 60th day of ICU admission. On comparison between the two groups, the duration of ICU LOS was significantly different in the two groups (median [Q1–Q3]: 12 [11–13] vs. 23 [19–28] days, P < 0.001). The number of days to death also differed significantly between the two groups (median [Q1–Q3]: 28 [21–38] vs. 24 [14–30] days, P = 0.009).
Table 3.
Comparison of patients who died
| Characteristic | Overall (n=91)a | Early (≤14 days) (n=21)a | Late (>14 days) (n=70)a | P b |
|---|---|---|---|---|
| Age | 60 (52–66) | 58 (53–66) | 60 (51–66) | >0.9 |
| Gender, n (%) | ||||
| Female | 18 (20) | 5 (24) | 13 (19) | 0.8 |
| Male | 73 (80) | 16 (76) | 57 (81) | |
| BMI | 32 (28–36) | 28 (27–33) | 33 (28–37) | 0.039 |
| SAPS3 | 77 (66–90) | 76 (69–85) | 78 (64–90) | 0.9 |
| CAD/HF, n (%) | 43 (47) | 8 (38) | 35 (50) | 0.3 |
| Obesity, n (%) | 57 (63) | 13 (62) | 44 (63) | >0.9 |
| HTN, n (%) | 50 (55) | 10 (48) | 40 (57) | 0.4 |
| DM, n (%) | 13 (14) | 1 (4.8) | 12 (17) | 0.3 |
| COPD, n (%) | 49 (54) | 10 (48) | 39 (56) | 0.5 |
| No COVID-19 medication given, n (%) | 30 (33) | 8 (38) | 22 (31) | 0.6 |
| Remdesivir, n (%) | 46 (51) | 10 (48) | 36 (51) | 0.8 |
| Tocilizumab, n (%) | 14 (15) | 3 (14) | 11 (16) | >0.9 |
| WBC | 7.30 (5.70–9.30) | 9.10 (7.00–10.10) | 7.05 (5.40–9.00) | 0.014 |
| AST | 48 (40–60) | 46 (36–56) | 49 (42–60) | 0.12 |
| ALT | 27 (17–36) | 30 (22–34) | 27 (15–36) | 0.2 |
| LDH | 389 (318–510) | 385 (300–503) | 402 (319–510) | 0.7 |
| CRP | 153 (131–181) | 169 (146–190) | 144 (128–170) | 0.007 |
| Prone, n (%) | 53 (58) | 14 (67) | 39 (56) | 0.4 |
| Dialysis, n (%) | 41 (45) | 9 (43) | 32 (46) | 0.8 |
| Duration of ICU stay (days) | 21 (15–26) | 12 (11–13) | 23 (19–28) | <0.001 |
| Reason for tracheostomy, n (%) | ||||
| Difficult weaning | 40 (44) | 9 (43) | 31 (44) | >0.9 |
| Difficult weaning | 51 (56) | 12 (57) | 39 (56) | |
| Time to intubation from hospital admission (days) | 5 (3–7) | 4 (3–6) | 5 (3–8) | 0.2 |
| Time to tracheostomy (days) | 21 (15–26) | 12 (11–13) | 23 (19–28) | <0.001 |
| Complications, n (%) | ||||
| No | 90 (99) | 21 (100) | 69 (99) | >0.9 |
| Yes | 1 (1.1) | 0 | 1 (1.4) | |
| Bleeding, n (%) | ||||
| No | 90 (99) | 21 (100) | 69 (99) | >0.9 |
| Yes | 1 (1.1) | 0 | 1 (1.4) | |
| Weaned from ventilator - no, n (%) | 91 (100) | 21 (100) | 70 (100) | |
| Decannulation - no, n (%) | 91 (100) | 21 (100) | 70 (100) | |
| Days to decannulation from tracheostomy | 14 (10–17) | 12 (8–16) | 14 (10–17) | 0.2 |
| Apnea during insertion of bronchoscope - yes, n (%) | 91 (100) | 21 (100) | 70 (100) | |
| On antiplatelets or anticoagulants, n (%) | ||||
| No | 3 (3.3) | 1 (4.8) | 2 (2.9) | 0.5 |
| Yes | 88 (97) | 20 (95) | 68 (97) | |
| Death | 91 (100) | 21 (100) | 70 (100) | |
| Days to death after tracheostomy | 25 (16–32) | 28 (21–38) | 24 (14–30) | 0.009 |
aMedian (IQR); n (%), bWilcoxon rank sum test; Fisher’s exact test; Pearson’s Chi-squared test. BMI: Body mass index, SAPS3: Simplified acute physiology score, CAD/HF: Coronary artery disease/heart failure, HTN: Hypertension, COPD: Chronic obstructive pulmonary disease, DM: Diabetes mellitus, WBC: White blood cell, AST: Aspartate aminotransferase, ALT: Alanine aminotransferase, LDH: Lactate dehydrogenase, CRP: C-reactive protein, IQR: Interquartile range, ICU: Intensive care unit, COVID-19: Coronavirus disease 2019
DISCUSSION
Tracheostomy is among the most common surgical procedures in patients with COVID-19 who eventually progress to ARDS. However, the timing of the procedure and related outcomes remain controversial. Studies conducted in the past have shown conflicting results with regard to the effect of the timing of tracheostomy on the ICU LOS and mortality rates. Studies assessing the influence of timing of tracheostomy on the ICU LOS, days to death after tracheostomy, and overall mortality are limited in setting of the current study.
Length of intensive care unit stay
In the current study, we divided the patients into early (≤14 days) and late (>14 days) groups to study the effect of the timing on various outcome parameters. The current study demonstrates that the duration of ICU stay differed significantly in the two groups (P < 0.001). In a study by Battaglini et al., including 153 patients that underwent tracheostomy, the ICU LOS was found to be significantly shorter in the early group.[26] Queen Elizabeth Hospital Birmingham COVID-19 airway team conducted a prospective observational cohort study to assess the 30-day outcomes of tracheostomy in COVID-19 patients. Their study revealed that tracheostomy performed within 14 days of intubation was associated with a shorter ICU LOS.[27] Mahmood et al. also concluded in their retrospective study that early tracheostomy is associated with a shorter ICU LOS.[28] The findings of these studies are similar to the findings of the current study. Contrary to this, a prospective observational study by Polok et al. derived to a conclusion that there is no effect of tracheostomy timing on the ICU LOS.[29] In another study by Mata-Castro et al., on 29 COVID-19 patients, early tracheostomy did not have an influence on the ICU LOS.[30]
Days to death after tracheostomy and overall mortality rate
Among the total number of patients that died, the patients in the early group survived longer as compared to patients in the late group (P = 0.009). The current study also demonstrates that there is no significant difference in the mortality rate between the early and late groups. Similarly, Battaglini et al. found no difference in the survival between the groups of patients that underwent tracheostomy before or after 15 days.[26] In the short report by Mata-Castro et al., there was no influence of timing of tracheostomy on the overall mortality rate.[30] A retrospective analysis by Kwak et al. concluded that late tracheostomy did not influence the mortality rate.[31] The findings of all these studies are in line with the findings of the current study.
This study has a few limitations. The design of the study was retrospective observational, in which we obtained all the data from the hospital records. However, a prospective study in this regard would add significant value
CONCLUSION
The current study concluded that early tracheostomy is associated with a significantly shorter ICU LOS in COVID-19 patients that have progressed to ARDS. Among the total number of patients that died, the patients in the early group survived longer as compared to patients in the late group. However, the timing of tracheostomy had no influence on the overall mortality rate in these patients.
Research quality and ethics statement
This study was approved by the Institutional Review Board/Ethics Committee at Dubai Scientific Research Ethics Committee, Dubai Health authority (Approval #: DSREC-06/2020_56; Approval date: September 17, 2020). The authors followed the applicable EQUATOR Network (http://www.equator-network.org/) guidelines, specifically the STROBE Guidelines, during the conduct of this research project.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Acknowledgments
The authors thank Dr. Amrita Prayag (MBBS, MS Pharmacology) for providing medical writing support.
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