Early Tracheostomy for Managing ICU Capacity During the COVID-19 Outbreak
2021; Elsevier BV; Volume: 161; Issue: 1 Linguagem: Inglês
10.1016/j.chest.2021.06.015
ISSN1931-3543
AutoresGonzalo Hernández, Francisco Javier Ramos, José M. Añón, Ramón Ortiz, Laura Colinas, Joan Ramón Masclans, Candelaria de Haro, Alfonso Ortega, Óscar Peñuelas, María del Mar Cruz-Delgado, Alfonso Canabal Berlanga, Oriol Plans, Concepción Vaquero, Gemma Rialp, Federico Gordo, Amanda Lesmes González de Aledo, María Martínez-Martínez, Juan Carlos Figueira, Alejandro Gomez-Carranza, Rocio Corrales, Andrea Castellví, Beatriz Castiñeiras, Fernando Frutos–Vivar, Jorge Prada, Raúl de Pablo, Antonio Naharro, Juan Carlos Montejo, Claudia Díaz, Alfonso Santos-Peral, Rebeca Padilla, Judith Marín‐Corral, Carmen Rodríguez-Solis, Juan Antonio Sánchez Giralt, Jorge Jiménez, Rafael Cuena, Santiago Pérez‐Hoyos, Oriol Roca,
Tópico(s)Respiratory Support and Mechanisms
ResumoBackgroundDuring the first wave of the COVID-19 pandemic, shortages of ventilators and ICU beds overwhelmed health care systems. Whether early tracheostomy reduces the duration of mechanical ventilation and ICU stay is controversial.Research QuestionCan failure-free day outcomes focused on ICU resources help to decide the optimal timing of tracheostomy in overburdened health care systems during viral epidemics?Study Design and MethodsThis retrospective cohort study included consecutive patients with COVID-19 pneumonia who had undergone tracheostomy in 15 Spanish ICUs during the surge, when ICU occupancy modified clinician criteria to perform tracheostomy in Patients with COVID-19. We compared ventilator-free days at 28 and 60 days and ICU- and hospital bed-free days at 28 and 60 days in propensity score-matched cohorts who underwent tracheostomy at different timings (≤ 7 days, 8-10 days, and 11-14 days after intubation).ResultsOf 1,939 patients admitted with COVID-19 pneumonia, 682 (35.2%) underwent tracheostomy, 382 (56%) within 14 days. Earlier tracheostomy was associated with more ventilator-free days at 28 days (≤ 7 days vs > 7 days [116 patients included in the analysis]: median, 9 days [interquartile range (IQR), 0-15 days] vs 3 days [IQR, 0-7 days]; difference between groups, 4.5 days; 95% CI, 2.3-6.7 days; 8-10 days vs > 10 days [222 patients analyzed]: 6 days [IQR, 0-10 days] vs 0 days [IQR, 0-6 days]; difference, 3.1 days; 95% CI, 1.7-4.5 days; 11-14 days vs > 14 days [318 patients analyzed]: 4 days [IQR, 0-9 days] vs 0 days [IQR, 0-2 days]; difference, 3 days; 95% CI, 2.1-3.9 days). Except hospital bed-free days at 28 days, all other end points were better with early tracheostomy.InterpretationOptimal timing of tracheostomy may improve patient outcomes and may alleviate ICU capacity strain during the COVID-19 pandemic without increasing mortality. Tracheostomy within the first work on a ventilator in particular may improve ICU availability. During the first wave of the COVID-19 pandemic, shortages of ventilators and ICU beds overwhelmed health care systems. Whether early tracheostomy reduces the duration of mechanical ventilation and ICU stay is controversial. Can failure-free day outcomes focused on ICU resources help to decide the optimal timing of tracheostomy in overburdened health care systems during viral epidemics? This retrospective cohort study included consecutive patients with COVID-19 pneumonia who had undergone tracheostomy in 15 Spanish ICUs during the surge, when ICU occupancy modified clinician criteria to perform tracheostomy in Patients with COVID-19. We compared ventilator-free days at 28 and 60 days and ICU- and hospital bed-free days at 28 and 60 days in propensity score-matched cohorts who underwent tracheostomy at different timings (≤ 7 days, 8-10 days, and 11-14 days after intubation). Of 1,939 patients admitted with COVID-19 pneumonia, 682 (35.2%) underwent tracheostomy, 382 (56%) within 14 days. Earlier tracheostomy was associated with more ventilator-free days at 28 days (≤ 7 days vs > 7 days [116 patients included in the analysis]: median, 9 days [interquartile range (IQR), 0-15 days] vs 3 days [IQR, 0-7 days]; difference between groups, 4.5 days; 95% CI, 2.3-6.7 days; 8-10 days vs > 10 days [222 patients analyzed]: 6 days [IQR, 0-10 days] vs 0 days [IQR, 0-6 days]; difference, 3.1 days; 95% CI, 1.7-4.5 days; 11-14 days vs > 14 days [318 patients analyzed]: 4 days [IQR, 0-9 days] vs 0 days [IQR, 0-2 days]; difference, 3 days; 95% CI, 2.1-3.9 days). Except hospital bed-free days at 28 days, all other end points were better with early tracheostomy. Optimal timing of tracheostomy may improve patient outcomes and may alleviate ICU capacity strain during the COVID-19 pandemic without increasing mortality. Tracheostomy within the first work on a ventilator in particular may improve ICU availability. FOR EDITORIAL COMMENT, SEE PAGE 8SARS-CoV-2, the coronavirus that is responsible for the COVID-19 pandemic, overwhelmed critical care resources, making the management of ICU capacity a crucial challenge worldwide. Up to 20% of patients hospitalized with COVID-19 require ICU admission,1Phua J. Weng L. Ling L. et al.Intensive care management of coronavirus disease 2019 (COVID-19): challenges and recommendations.Lancet Respir. 2020; 8: 506-517Abstract Full Text Full Text PDF PubMed Scopus (1035) Google Scholar more than 50% of those admitted to ICUs need invasive ventilatory support,2Aziz S. Arabi Y.M. Alhazzani W. et al.Managing ICU surge during the COVID-19 crisis: rapid guidelines.Intensive Care Med. 2020; 46: 1303-1325Crossref PubMed Scopus (259) Google Scholar and 30% of those undergoing mechanical ventilation eventually undergo a tracheostomu,3Karagiannidis C. Mostert C. Hentschker C. et al.Case characteristics, resource use, and outcomes of 10021 patients with COVID-19 admitted to 920 German hospitals: an observational study.Lancet. 2020; 8: 853-862Scopus (547) Google Scholar because of the need for relatively prolonged respiratory support or airway problems (eg, laryngeal edema associated with COVID-19 complicating airway management),4McGrath B.A. Wallace S. Goswamy J. Laryngeal oedema associated with COVID-19 complicating airway management.Anaesthesia. 2020; 75: 962-977Crossref PubMed Scopus (67) Google Scholar making it essential to optimize the patient's prognosis and the use of ICU beds and ventilators. Various strategies have been suggested to overcome the shortage of these resources during the pandemic.1Phua J. Weng L. Ling L. et al.Intensive care management of coronavirus disease 2019 (COVID-19): challenges and recommendations.Lancet Respir. 2020; 8: 506-517Abstract Full Text Full Text PDF PubMed Scopus (1035) Google Scholar,2Aziz S. Arabi Y.M. Alhazzani W. et al.Managing ICU surge during the COVID-19 crisis: rapid guidelines.Intensive Care Med. 2020; 46: 1303-1325Crossref PubMed Scopus (259) Google Scholar FOR EDITORIAL COMMENT, SEE PAGE 8 Some data from studies carried out before the COVID-19 pandemic suggest that early tracheostomy reduces the length of mechanical ventilation and ICU stay,5Wang R. Pan C. Wang X. Xu F. Jiang S. Li M. The impact of tracheostomy in critically ill patients undergoing mechanical ventilation: a meta-analysis of randomized controlled clinical trials with trial sequential analysis.Heart Lung. 2019; 48: 46-54Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 6Hosokawa K. Nishimura M. Egi M. Vincent J.L. Timing of tracheostomy in ICU patients: a systematic review of randomized controlled trials.Crit Care. 2015; 19: 424Crossref PubMed Scopus (135) Google Scholar, 7Liu C. Rudmik L. A cost-effectiveness analysis of early vs late tracheostomy.Otolaryngol Head Neck Surg. 2016; 142: 981-987Google Scholar, 8Chorath K. Hoang A. Rajasekaran K. et al.Association of early vs late tracheostomy placement with pneumonia and ventilator days in critically ill patients. A meta-analysis.JAMA Otolaryngol Head Neck Surg. 2021; 147: 450-459Crossref PubMed Scopus (49) Google Scholar reduces ventilator-associated pneumonia,8Chorath K. Hoang A. Rajasekaran K. et al.Association of early vs late tracheostomy placement with pneumonia and ventilator days in critically ill patients. A meta-analysis.JAMA Otolaryngol Head Neck Surg. 2021; 147: 450-459Crossref PubMed Scopus (49) Google Scholar and improves cost-effectiveness,7Liu C. Rudmik L. A cost-effectiveness analysis of early vs late tracheostomy.Otolaryngol Head Neck Surg. 2016; 142: 981-987Google Scholar without modifying the mortality rate. However, methodologic pitfalls in these studies preclude firm conclusions, and scant data are available from patients with COVID-19.9Aviles-Jurado F.X. Prieto-Alhambra D. González-Sánchez N. et al.Timing, complications, and safety of tracheostomy in critically ill patients with COVID-19.JAMA Otolaryngol Head Neck Surg. 2020; 147: 1-8PubMed Google Scholar Furthermore, performing tracheostomy and post-tracheostomy care generate aerosols, placing health care professionals at risk, making it essential to protect them too.10McGrath B.A. Brenner M. Warrillow S. et al.Tracheostomy in the COVID-19 era: global and multidisciplinary guidance.Lancet Respir Med. 2020; 8: 717-725Abstract Full Text Full Text PDF PubMed Scopus (283) Google Scholar General guidelines on managing critically ill patients with COVID-19 include recommendations regarding tracheostomy,11Alhazzani W. Møller M.H. Arabi Y.M. et al.Surviving Sepsis Campaign: guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19).Intensive Care Med. 2020; 46: 854-887Crossref PubMed Scopus (1354) Google Scholar,12Berlin D.A. Gulick R.M. Martinez F.J. Severe Covid-19.N Engl J Med. 2020; 383: 2451-2460Crossref PubMed Scopus (978) Google Scholar and clinical decisions have been guided by recommendations based on expert opinion.10McGrath B.A. Brenner M. Warrillow S. et al.Tracheostomy in the COVID-19 era: global and multidisciplinary guidance.Lancet Respir Med. 2020; 8: 717-725Abstract Full Text Full Text PDF PubMed Scopus (283) Google Scholar,13Chao T.N. Braslow B.M. Martin N.D. et al.Tracheostomy in ventilated patients with COVID-19.Ann Surg. 2020; 272: e30-e32Crossref PubMed Scopus (79) Google Scholar, 14Chiesa-Estomba C.M. Lechien J.R. Calvo-Henriquez C. et al.Systematic review of international guidelines for tracheostomy in COVID-19 patients.Oral Oncol. 2020; 108: 104844Crossref PubMed Scopus (57) Google Scholar, 15Delides A. Maragoudakis P. Nikolopoulos T. Timing of tracheostomy in intubated patients with COVID-19.Otolaryngol Head Neck Surg. 2020; 163: 328-329Crossref PubMed Scopus (10) Google Scholar, 16Ferri E. Nata F.B. Pedruzzi B. et al.Indications and timing for tracheostomy in patients with SARS CoV2-related.Eur Arch Otorhinolaryngol. 2020; 277: 2403-2404Crossref PubMed Scopus (27) Google Scholar, 17Lamb C.R. Desai N.R. Angel L. et al.Use of Tracheostomy During the COVID-19 Pandemic: American College of Chest Physicians/American Association for Bronchology and Interventional Pulmonology/Association of Interventional Pulmonology Program Directors Expert Panel Report.Chest. 2020; 158: 1499-1514Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar Expert recommendations on timing tracheostomy during the COVID-19 pandemic vary widely. One panel concluded that no specific timing could be recommended17Lamb C.R. Desai N.R. Angel L. et al.Use of Tracheostomy During the COVID-19 Pandemic: American College of Chest Physicians/American Association for Bronchology and Interventional Pulmonology/Association of Interventional Pulmonology Program Directors Expert Panel Report.Chest. 2020; 158: 1499-1514Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar; other panels recommend 7 days,18Mattioli F. Fermi M. Ghirelli M. et al.Tracheostomy in the COVID-19 pandemic.Eur Arch Otorhinolaryngol. 2020; 277: 2133-2135Crossref PubMed Scopus (71) Google Scholar 10 days,10McGrath B.A. Brenner M. Warrillow S. et al.Tracheostomy in the COVID-19 era: global and multidisciplinary guidance.Lancet Respir Med. 2020; 8: 717-725Abstract Full Text Full Text PDF PubMed Scopus (283) Google Scholar 14 days,14Chiesa-Estomba C.M. Lechien J.R. Calvo-Henriquez C. et al.Systematic review of international guidelines for tracheostomy in COVID-19 patients.Oral Oncol. 2020; 108: 104844Crossref PubMed Scopus (57) Google Scholar,19Volo T. Stritoni P. Battel I. et al.Elective tracheostomy during COVID-19 outbreak: to whom, when, how? Early experience from Venice, Italy.Eur Arch Otorhinolaryngol. 2021; 278: 781-789Crossref PubMed Scopus (42) Google Scholar or 21 days13Chao T.N. Braslow B.M. Martin N.D. et al.Tracheostomy in ventilated patients with COVID-19.Ann Surg. 2020; 272: e30-e32Crossref PubMed Scopus (79) Google Scholar,16Ferri E. Nata F.B. Pedruzzi B. et al.Indications and timing for tracheostomy in patients with SARS CoV2-related.Eur Arch Otorhinolaryngol. 2020; 277: 2403-2404Crossref PubMed Scopus (27) Google Scholar,20Michetti C.P. Burlew C.C. Bulger E.M. Davis K.A. Spain D.A. Performing tracheostomy during the COVID-19 pandemic: guidance and recommendations from the Critical Care and Acute Care Surgery Committees of the American Association for the Surgery of Trauma.Trauma Surg Acute Care Open. 2020; 5e000482Crossref Scopus (81) Google Scholar after intubation. These recommendations aim to balance the benefits of earlier tracheostomy for patients and health care systems based on evidence from before the COVID-19 pandemic, while minimizing risk for health care professionals, because infectivity declines over time.10McGrath B.A. Brenner M. Warrillow S. et al.Tracheostomy in the COVID-19 era: global and multidisciplinary guidance.Lancet Respir Med. 2020; 8: 717-725Abstract Full Text Full Text PDF PubMed Scopus (283) Google Scholar Studies from before the COVID-19 pandemic preclude definitive conclusions on the best timing of tracheostomy because they used heterogeneous outcome measures and definitions of early tracheostomy (2-14 days); moreover, they relied on physicians' predictions of which patients would require prolonged mechanical ventilation, limiting the ability of randomized trials21Young D. Harrison D.A. Cuthbertson B.H. Rowan K. TracMan CollaboratorsEffect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation. The TracMan randomized trial.JAMA. 2013; 309: 2121-2129Crossref PubMed Scopus (443) Google Scholar, 22Diaz-Prieto A. Mateu A. Gorriz M. et al.A randomized clinical trial for the timing of tracheostomy in critically ill patients: factors precluding inclusion in a single center study.Crit Care. 2014; 18: 585Crossref PubMed Scopus (37) Google Scholar, 23Terragni P.P. Antonelli M. Fumagalli R. et al.Early vs late tracheostomy for prevention of pneumonia in mechanically ventilated adult ICU patients. A randomized controlled trial.JAMA. 2010; 303: 1483-1489Crossref PubMed Scopus (380) Google Scholar and of meta-analyses5Wang R. Pan C. Wang X. Xu F. Jiang S. Li M. The impact of tracheostomy in critically ill patients undergoing mechanical ventilation: a meta-analysis of randomized controlled clinical trials with trial sequential analysis.Heart Lung. 2019; 48: 46-54Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar,6Hosokawa K. Nishimura M. Egi M. Vincent J.L. Timing of tracheostomy in ICU patients: a systematic review of randomized controlled trials.Crit Care. 2015; 19: 424Crossref PubMed Scopus (135) Google Scholar,8Chorath K. Hoang A. Rajasekaran K. et al.Association of early vs late tracheostomy placement with pneumonia and ventilator days in critically ill patients. A meta-analysis.JAMA Otolaryngol Head Neck Surg. 2021; 147: 450-459Crossref PubMed Scopus (49) Google Scholar to demonstrate a clear benefit for early tracheostomy. Studies carried out after the appearance of COVID-19 have additional methodologic pitfalls. Given the difficulties in performing randomized trials under pandemic conditions, all available evidence comes from observational studies. Moreover, the time-dependent outcomes of these studies are especially prone to selection, immortal-time, and competing-risk biases.24Wolkewitz M. Puljak L. Methodological challenges of analysing COVID-19 data during the pandemic.BMC Med Res Methodol. 2020; 20: 81Crossref PubMed Scopus (62) Google Scholar However, some characteristics of the COVID-19 pandemic actually favor the analysis of tracheostomy timing. COVID-19 is a more homogeneous clinical condition in which it is easier to predict whether a patient will require prolonged mechanical ventilation.3Karagiannidis C. Mostert C. Hentschker C. et al.Case characteristics, resource use, and outcomes of 10021 patients with COVID-19 admitted to 920 German hospitals: an observational study.Lancet. 2020; 8: 853-862Scopus (547) Google Scholar,25Wunsch H. Mechanical ventilation in COVID-19: interpreting the current epidemiology.Am J Respir Crit Care Med. 2020; 202: 1-4Crossref PubMed Scopus (148) Google Scholar The surge in ICU admissions resulted in a high volume of tracheostomies, and tracheostomies were performed earlier to allow patients to be discharged to wards. Finally, about 30% to 50% of patients with COVID-19 die while receiving mechanical ventilation, powering the failure-free days outcome, but making it futile for many of these patients.17Lamb C.R. Desai N.R. Angel L. et al.Use of Tracheostomy During the COVID-19 Pandemic: American College of Chest Physicians/American Association for Bronchology and Interventional Pulmonology/Association of Interventional Pulmonology Program Directors Expert Panel Report.Chest. 2020; 158: 1499-1514Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar,26Yehya N. Harhay M.O. Curley M.A.Q. Schoenfeld D.A. Reeder R.W. Reappraisal of ventilator-free days in critical care research.Am J Respir Crit Care Med. 2019; 200: 828-836Crossref PubMed Scopus (190) Google Scholar Specific measures of the impact of different treatment strategies on the availability of ICU resources under these conditions are lacking. Composite outcome measures based on the concept of failure-free days summarize the effect of an intervention on morbidity in the presence of the competing event of death.26Yehya N. Harhay M.O. Curley M.A.Q. Schoenfeld D.A. Reeder R.W. Reappraisal of ventilator-free days in critical care research.Am J Respir Crit Care Med. 2019; 200: 828-836Crossref PubMed Scopus (190) Google Scholar Thus, we used ventilator-free days (VFDs) and ICU and hospital bed-free days (BFDs) as measures of the effectiveness of tracheostomy in freeing up ICU and hospital resources during the COVID-19 outbreak to determine the best timing of tracheostomy to optimize the clinical course of patients and the use of ventilators and beds during the surge. This retrospective cohort study included all consecutive patients in 15 Spanish ICUs diagnosed with hypoxemic respiratory failure secondary to reverse-transcriptase polymerase chain reaction-confirmed COVID-19 pneumonia who underwent tracheostomy between February 15 and May 15, 2020. During the outbreak, attending physicians decided who underwent tracheostomy when and how based on ICU occupancy and anticipated benefit to the patient of tracheostomy. Criteria for tracheostomy included anticipated need for prolonged mechanical ventilation (≥ 10 days since tracheostomy), ventilator parameters (positive end-expiratory pressure ≤ 12 cm H2O, Fio2 ≤ 60%), no anticipated need for future prone positioning, any patient within 24 to 36 h of being administered extracorporeal membrane oxygenation, and absence of negative prognostic indicators (ie, high probability of death, coagulopathy, extrapulmonary organ dysfunction other than acute renal failure with dialysis). Outcomes were compared with patients who underwent early vs late tracheostomy, with the following cutoffs: ≤ 7 days, 8 to 10 days, and 11 to 14 days. The institutional review boards of the participating hospitals approved the study (the departments of health of the regional governments to which these hospitals are affiliated: Madrid, Catalonia, Mallorca, and Castilla-la Mancha), waiving the need for written informed consent because of the retrospective and observational nature of the study (CEIM Complejo Hospitalario de Toledo, 10/7/2020, no. 546). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for reporting observational studies were followed. To prevent competing-risk bias, we excluded patients with factors associated with tracheostomy: admission to the ICU with positive polymerase chain reaction results for COVID-19, but without indications for mechanical ventilation for COVID-19 pneumonia; admission after otorhinolaryngology surgery; low level of consciousness; swallowing dysfunction; neuromuscular disease other than ICU-acquired weakness; tracheostomy; advanced directives to withhold life-sustaining interventions; or being expected to die before hospital discharge. To prevent residual selection bias resulting from the lack of randomization of the timing of tracheostomy, we matched cohorts based on propensity scores. Propensity scores were calculated using variables predictive of the timing of tracheostomy in the ICU (age, sex, comorbidities, Acute Physiology and Chronic Evaluation II score at ICU admission, extrapulmonary organ failures at ICU admission, type of ICU), additional covariates for patients with COVID-19 (date of ICU admission, time from clinical presentation to invasive mechanical ventilation, and medical treatment with corticoids or remdesivir), and variables predictive of tracheostomy or prolonged mechanical ventilation (need for reintubation before tracheostomy, neurologic failure at ICU admission, and underlying chronic respiratory disease). We excluded post-tracheostomy factors that could lead to immortal-time bias, except the use of high-flow oxygen therapy during weaning. For matched comparisons, patients in the late tracheostomy cohort were selected according to the propensity score from among the remaining patients (≥ 8 days, ≥ 11 days, and ≥ 15 days, respectively). We collected data regarding patients' characteristics, course of COVID-19, ICU and hospital admission, severity of illness at ICU admission and at tracheostomy, respiratory and COVID-19 treatments, extubation episodes before tracheostomy (counting the time off ventilator in the calculation of VFD), weaning or decannulation failure (counting the time off ventilator before weaning failure in the calculation of VFD), ICU and hospital length of stay (LOS), ICU readmission (counting the time between admissions in the calculation of BFD), course of mechanical ventilation and tracheostomy, vital status at ICU and hospital discharge, and cause of death. We also recorded tracheostomy-related and post-tracheostomy-related ICU complications (e-Appendix 1). The primary outcome was VFD at 28 days, calculated as VFD28 = 28 – x, where x represents the number of days from intubation to liberation from ventilation or death. Secondary outcomes included VFD at 60 days (VFD60 = 60 – x, where x represents the number of days from intubation to liberation from ventilation or death) and modified ICU or hospital BFD at 28 days (BFD28 = 28 – y, where y represents the number of days from ICU or hospital admission to discharge to the ward or home or death) and at 60 days (BFD60 = 60 – y, where y represents the number of days from ICU or hospital admission to discharge to the ward or home or death). Therefore, the value of these variables is 0 when the patient uses the resource (ventilator or bed) for longer than the specified period (28 or 60 days). To compare groups of patients who underwent tracheostomy in different timeframes (< 7 days, 8-10 days, or 11-14 days after intubation) within the entire cohort (unmatched patients), we used the χ 2Aziz S. Arabi Y.M. Alhazzani W. et al.Managing ICU surge during the COVID-19 crisis: rapid guidelines.Intensive Care Med. 2020; 46: 1303-1325Crossref PubMed Scopus (259) Google Scholar test or Fisher exact test for categorical variables and the analysis of variance or Kruskal-Wallis test for continuous variables, as appropriate. We used Kaplan-Meier plots to determine the probability of being mechanically ventilated in each tracheostomy-timing group, and we used the log-rank test to compare this probability among groups. To analyze the relationship among the timing of tracheostomy, duration of mechanical ventilation, ICU LOS, and hospital LOS, we used locally estimated scatterplot smoothing. To determine the effect of timing of tracheostomy on outcomes (VFD28, VFD60, BFD28, and BFD60) we compared propensity score-matched cohorts of patients who underwent tracheostomy at different time points after intubation (≤ 7 days, 8-10 days, and 11-14 days). e-Appendix 1 presents detailed information about the variables included in the propensity score matching. In constituting all propensity score-matched cohorts to be compared, we used 1:1 nearest-neighbor matching without replacement and a caliper (maximum permitted difference between matched subjects) of 0.2 SD of the logit of the propensity score. An exploratory analysis also compared outcomes between two additional matched cohorts to assess differences among different timings of early tracheostomy (≤ 7 days vs 8-10 days and ≤ 7 days vs 11-14 days). We used Stata version 14 software (StataCorp LLC) and R version 3.6.3 software (R Foundation for Statistical Computing) for all analyses, using the MatchIt package from R for propensity score matching. Two-tailed P values of ≤ .05 were considered statistically significant. Participating ICUs admitted a total of 1,939 patients with COVID-19 pneumonia during the study period; 682 patients (35.2%) underwent tracheostomy during the ICU stay, 382 patients (56%) within 14 days of intubation. The centers where and dates when tracheostomies were performed are presented in e-Table 1 and e-Figure 1. Table 1 summarizes the baseline characteristics of the entire population classified according to the timing of tracheostomy (≤ 7 days, 8-10 days, 11-14 days, 15-20 days, and ≥ 21 days) (e-Table 2). Figure 1 shows the probability of continuing mechanical ventilation for the groups of patients who underwent tracheostomy according to the timing of tracheostomy, as a surrogate for total time receiving mechanical ventilation.Table 1Baseline Patient Characteristics in the Entire Population (Unmatched Samples), According to Time From Intubation to TracheostomyaDetailed information in e-Table 2.CharacteristicTime to Tracheostomy (Days From Intubation)P Value≤ 7 (n = 65)8-10 (n = 126)11-14 (n = 191)15-20 (n = 197)≥ 21 (n = 103)Age, y62 (55-70)65 (56-69)64 (57-71)64 (57-69)65 (56-72).863Male sex42 (64.6)88 (69.8)136 (71.2)149 (73.8)74 (75.5).563ComorbiditiesbCoexisting conditions were assessed according to the Charlson Comorbidity Index, in which 22 clinical conditions are scored regarding the risk of death; scores range from 0 to 37, with higher scores indicating a higher risk of death. BMI > 30 kg/m228 (43.1)52 (41.3)88 (46.1)74 (36.6)41 (41.8).450 Heart disease6 (9.2)10 (7.9)16 (8.4)15 (7.4)20 (20.4).005 COPD2 (3.1)2 (2.4)11 (5.8)8 (4)4 (4.1).651 Other respiratory disease6 (9.2)6 (4.8)24 (12.6)31 (15.3)15 (15.3).042COVID-19 course Time from symptom onset to ICU admission, d9 (6-12)8 (6-12)9 (7-12)10 (7-14)9 (6-14).217 Time from intubation to tracheostomy, d6 (5-7)9 (8-10)13 (12-13)17 (16-19)24 (22-29)< .001 Time from tracheostomy to weaning, dcWeaning was defined as consecutive 24 h disconnected from mechanical ventilation.7 (1-19)7 (0-17)6 (0-12)8 (0-22)11 (0-19).213Treatments HFOT during weaning23 (35.4)45 (35.7)53 (27.8)36 (17.8)25 (25.5).003 Remdesivir2 (3.1)13 (10.3)13 (6.8)10 (5)9 (9.2).217 Steroids51 (78.5)107 (84.9)153 (80.1)149 (73.8)79 (80.6).177 Rescue ARDS therapydThe APACHE II score was calculated from 17 variables recorded on the day of admission to the ICU; scores range from 0 to 71 points, with higher scores indicating more severe disease.58 (89.2)120 (95.2)172 (90.1)179 (88.6)90 (91.8).336Severity at ICU admission Hemodynamic failure21 (33.9)51 (42.2)73 (41)95 (48)49 (56.3).043 Renal failure22 (33.9)36 (28.6)73 (38.2)59 (29.2)35 (35.7).274 No. of failed organs2 (1-3)2 (1-3)2 (1-3)2 (1-3)2 (1-3).687 APACHE II scoredThe APACHE II score was calculated from 17 variables recorded on the day of admission to the ICU; scores range from 0 to 71 points, with higher scores indicating more severe disease.13 (8-16)13 (9-18)15 (10-18)15 (11-18)15 (11-17).212Complications during ICU stay Weaning failure5 (7.7)12 (9.5)26 (13.6)14 (7.1)27 (26.2)< .001 VAP22 (33.9)52 (41.3)68 (35.6)86 (42.6)55 (56.1).012 Sepsis13 (20)34 (27)53 (27.8)58 (28.7)52 (53.1)< .001 Hematologic15 (23.1)40 (31.8)47 (24.6)66 (32.7)43 (43.9).009 Death18 (27.7)47 (37.3)71 (37.2)76 (37.6)30 (30.6).468Data are presented as No. (%) or median (interquartile range). APACHE = Acute Physiology and Chronic Evaluation; HFOT = high-flow oxygen therapy; VAP = ventilator-associated pneumonia.a Detailed information in e-Table 2.b Coexisting conditions were assessed according to the Charlson Comorbidity Index, in which 22 clinical conditions are scored regarding the risk of death; scores range from 0 to 37, with higher scores indicating a higher risk of death.c Weaning was defined as consecutive 24 h disconnected from mechanical ventilation.d The APACHE II score was calculated from 17 variables recorded on the day of admission to the ICU; scores range from 0 to 71 points, with higher scores indicating more severe disease. Open table in a new tab Data are presented as No. (%) or median (interquartile range). APACHE = Acute Physiology and Chronic Evaluation; HFOT = high-flow oxygen therapy; VAP = ventilator-associated pneumonia. Primary and all the secondary outcomes except hospital BFD28 differed significantly depending on the timing of tracheostomy. Locally estimated scatterplot smoothing showed that time receiving mechanical ventilation, ICU LOS, and hospital LOS increased with the time from intubation to tracheostomy (e-Figs 2, 3, 4). e-Table 3 summarizes the outcomes for the entire population broken down by time frames when tracheostomy was performed after intubation (unmatched cohorts). Tables 2, 3, and 4 report the results of the comparisons between the matched cohorts (≤7 days vs > 7 days, 8-10 days vs > 10 days, and 11-14 days vs > 14 days, respectively); the detailed characteristics of the patients in these cohorts are presented in e-Tables 4, 5, and 6. No significant differences in mortality were found between cohorts.Table 2Results for the Primary and Secondary Outcomes in the Propensity-Matched Cohorts of Patients With Tracheostomy Performed ≤ 7 Days vs > 7 Days After IntubationO
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