Percutaneous Dilational Tracheostomy at the Epicenter of the SARS-CoV-2 Pandemic: Impact on Critical Care Resource Utilization and Early Outcomes.

BACKGROUND: The COVID-19 pandemic overwhelmed New York City hospitals early in the pandemic. Shortages of ventilators and sedatives prompted tracheostomy earlier than recommended by professional societies. This study evaluates the impact of percutaneous dilational tracheostomy (PDT) in COVID+ patients on critical care capacity. METHODS: This is a single-institution prospective case series of mechanically ventilated COVID-19 patients undergoing PDT from April 1 to June 4, 2020 at a public tertiary care center. RESULTS: Fifty-five patients met PDT criteria and underwent PDT at a median of 13 days (IQR 10, 18) from intubation. Patient characteristics are found in Table 1. Intravenous midazolam, fentanyl, and cisatracurium equivalents were significantly reduced 48 hours post-PDT (Table 2). Thirty-five patients were transferred from the ICU and liberated from the ventilator. Median time from PDT to ventilator liberation and ICU discharge was 10 (IQR 4, 14) and 12 (IQR 8, 17) days, respectively. Decannulation occurred in 45.5% and 52.7% were discharged from acute inpatient care (Figure 1). Median follow-up for the study was 62 days. Four patients had bleeding complications postoperatively and 11 died during the study period. Older age was associated with increased odds of complication (OR 1.12, 95% CI 1.04, 1.23) and death (OR=1.15, 95% CI 1.05, 1.30). All operators tested negative for COVID-19 during the study period. CONCLUSION: These findings suggest COVID-19 patients undergoing tracheostomy within the standard time frame can improve critical care capacity in areas strained by the pandemic with low risk to operators. Long-term outcomes after PDT deserve further study.

Tracheostomy is Safe in Patients with Prolonged Intubation After Coronavirus Disease 2019 Infection.

BACKGROUND: Tracheostomy improves outcomes for critically ill patients requiring prolonged mechanical ventilation. Data are limited on the use and benefit of tracheostomies for intubated, critically ill coronavirus disease 2019 (COVID-19) patients. During the surge in COVID 19 infections in metropolitan New York/New Jersey, our hospital cared for many COVID-19 patients who required prolonged intubation. This study describes the outcomes in COVID-19 patients who underwent tracheostomy. METHODS: We present a case series of patients with COVID-19 who underwent tracheostomy at a single institution. Tracheostomies were performed on patients with prolonged mechanical ventilation beyond 3 wk. Patient demographics, medical comorbidities, and ventilator settings prior to tracheostomy were reviewed. Primary outcome was in-hospital mortality. Secondary outcomes included time on mechanical ventilation, length of ICU and hospital stay, and discharge disposition. RESULTS: Fifteen COVID-19 patients underwent tracheostomy at an average of 31 d post intubation. Two patients (13%) died. Half of our cohort was liberated from the ventilator (8 patients, 53%), with an average time to liberation of 14 ± 6 d after tracheostomy. Among patients off mechanical ventilation, 5 (63%) had their tracheostomies removed prior to discharge. The average intensive care length of stay was 47 ± 13 d (range 29-74 d) and the average hospital stay was 59 ± 16 d (range 34-103 d). CONCLUSIONS: This study reports promising outcomes in COVID-19 patients with acute respiratory failure and need for prolonged ventilation who undergo tracheostomy during their hospitalization. Further research is warranted to establish appropriate indications for tracheostomy in COVID-19 and confirm outcomes.

Percutaneous and Open Tracheostomy in Patients With COVID-19: The Weill Cornell Experience in New York City.

OBJECTIVE: Report long-term tracheostomy outcomes in patients with COVID-19. STUDY DESIGN: Review of prospectively collected data. METHODS: Prospectively collected data were extracted for adults with COVID-19 undergoing percutaneous or open tracheostomy between April 4, 2020 and June 2, 2020 at a major medical center in New York City. The primary endpoint was weaning from mechanical ventilation. Secondary outcomes included sedation weaning, decannulation, and discharge. RESULTS: One hundred one patients underwent tracheostomy, including 48 percutaneous (48%) and 53 open (52%), after a median intubation time of 24 days (IQR 20, 31). The most common complication was minor bleeding (n = 18, 18%). The all-cause mortality rate was 15% and no deaths were attributable to the tracheostomy. Eighty-three patients (82%) were weaned off mechanical ventilation, 88 patients (87%) were weaned off sedation, and 72 patients (71%) were decannulated. Censored median times from tracheostomy to sedation and ventilator weaning were 8 (95% CI 6-11) and 18 (95% CI 14-22) days, respectively (uncensored: 7 and 15 days). Median time from tracheostomy to decannulation was 36 (95% CI 32-47) days (uncensored: 32 days). Of those decannulated, 82% were decannulated during their index admission. There were no differences in outcomes or complication rates between percutaneous and open tracheostomy. Likelihood of discharge from the ICU was inversely related to intubation time, though the clinical relevance of this was small (HR 0.97, 95% CI 0.943-0.998; P = .037). CONCLUSION: Tracheostomy by either percutaneous or open technique facilitated sedation and ventilator weaning in patients with COVID-19 after prolonged intubation. Additional study on the optimal timing of tracheostomy in patients with COVID-19 is warranted. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:E2849-E2856, 2021.

Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.

BACKGROUND: Convalescent plasma and hyperimmune immunoglobulin may reduce mortality in patients with viral respiratory diseases, and are being investigated as potential therapies for coronavirus disease 2019 (COVID-19). A thorough understanding of the current body of evidence regarding benefits and risks of these interventions is required.  OBJECTIVES: Using a living systematic review approach, to assess whether convalescent plasma or hyperimmune immunoglobulin transfusion is effective and safe in the treatment of people with COVID-19; and to maintain the currency of the evidence. SEARCH METHODS: To identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Global literature on coronavirus disease Research Database, MEDLINE, Embase, the Cochrane COVID-19 Study Register, the Epistemonikos COVID-19 L*OVE Platform, and trial registries. Searches were done on 17 March 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating convalescent plasma or hyperimmune immunoglobulin for COVID-19, irrespective of disease severity, age, gender or ethnicity. For safety assessments, we also included non-controlled non-randomised studies of interventions (NRSIs) if 500 or more participants were included. We excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies evaluating standard immunoglobulin. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. To assess bias in included studies, we used the Cochrane 'Risk of Bias 2' tool for RCTs, and for NRSIs, the assessment criteria for observational studies, provided by Cochrane Childhood Cancer. We rated the certainty of evidence, using the GRADE approach, for the following outcomes: all-cause mortality, improvement and worsening of clinical status (for individuals with moderate to severe disease), development of severe clinical COVID-19 symptoms (for individuals with asymptomatic or mild disease), quality of life (including fatigue and functional independence), grade 3 or 4 adverse events, and serious adverse events. MAIN RESULTS: We included 13 studies (12 RCTs, 1 NRSI) with 48,509 participants, of whom 41,880 received convalescent plasma. We did not identify any completed studies evaluating hyperimmune immunoglobulin. We identified a further 100 ongoing studies evaluating convalescent plasma or hyperimmune immunoglobulin, and 33 studies reporting as being completed or terminated. Individuals with a confirmed diagnosis of COVID-19 and moderate to severe disease Eleven RCTs and one NRSI investigated the use of convalescent plasma for 48,349 participants with moderate to severe disease. Nine RCTs compared convalescent plasma to placebo treatment or standard care alone, and two compared convalescent plasma to standard plasma (results not included in abstract). Effectiveness of convalescent plasma We included data on nine RCTs (12,875 participants) to assess the effectiveness of convalescent plasma compared to placebo or standard care alone.  Convalescent plasma does not reduce all-cause mortality at up to day 28 (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.92 to 1.05; 7 RCTs, 12,646 participants; high-certainty evidence). It has little to no impact on clinical improvement for all participants when assessed by liberation from respiratory support (RR not estimable; 8 RCTs, 12,682 participants; high-certainty evidence). It has little to no impact on the chance of being weaned or liberated from invasive mechanical ventilation for the subgroup of participants requiring invasive mechanical ventilation at baseline (RR 1.04, 95% CI 0.57 to 1.93; 2 RCTs, 630 participants; low-certainty evidence). It does not reduce the need for invasive mechanical ventilation (RR 0.98, 95% CI 0.89 to 1.08; 4 RCTs, 11,765 participants; high-certainty evidence). We did not identify any subgroup differences.  We did not identify any studies reporting quality of life, and therefore, do not know whether convalescent plasma has any impact on quality of life. One RCT assessed resolution of fatigue on day 7, but we are very uncertain about the effect (RR 1.21, 95% CI 1.02 to 1.42; 309 participants; very low-certainty evidence).  Safety of convalescent plasma We included results from eight RCTs, and one NRSI, to assess the safety of convalescent plasma. Some of the RCTs reported on safety data only for the convalescent plasma group.  We are uncertain whether convalescent plasma increases or reduces the risk of grade 3 and 4 adverse events (RR 0.90, 95% CI 0.58 to 1.41; 4 RCTs, 905 participants; low-certainty evidence), and serious adverse events (RR 1.24, 95% CI 0.81 to 1.90; 2 RCTs, 414 participants; low-certainty evidence).  A summary of reported events of the NRSI (reporting safety data for 20,000 of 35,322 transfused participants), and four RCTs reporting safety data only for transfused participants (6125 participants) are included in the full text. Individuals with a confirmed diagnosis of SARS-CoV-2 infection and asymptomatic or mild disease We identified one RCT reporting on 160 participants, comparing convalescent plasma to placebo treatment (saline).  Effectiveness of convalescent plasma We are very uncertain about the effect of convalescent plasma on all-cause mortality (RR 0.50, 95% CI 0.09 to 2.65; very low-certainty evidence). We are uncertain about the effect of convalescent plasma on developing severe clinical COVID-19 symptoms (RR not estimable; low-certainty evidence).  We identified no study reporting quality of life.  Safety of convalescent plasma We do not know whether convalescent plasma is associated with a higher risk of grade 3 or 4 adverse events (very low-certainty evidence), or serious adverse events (very low-certainty evidence). This is a living systematic review. We search weekly for new evidence and update the review when we identify relevant new evidence. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review. AUTHORS' CONCLUSIONS: We have high certainty in the evidence that convalescent plasma for the treatment of individuals with moderate to severe disease does not reduce mortality and has little to no impact on measures of clinical improvement. We are uncertain about the adverse effects of convalescent plasma. While major efforts to conduct research on COVID-19 are being made, heterogeneous reporting of outcomes is still problematic. There are 100 ongoing studies and 33 studies reporting in a study registry as being completed or terminated. Publication of ongoing studies might resolve some of the uncertainties around hyperimmune immunoglobulin therapy for people with any disease severity, and convalescent plasma therapy for people with asymptomatic or mild disease.

Early Data From Case Series of Tracheostomy in Patients With SARS-CoV-2.

Thirty-eight tracheostomies were performed on patients with respiratory failure secondary to SARS-CoV-2 infection over the month of April at North Shore University Hospital and Lenox Hill Hospital (members of Northwell Health System in Long Island and New York City). Follow-up by May 14 revealed that 21 (55.2%) had been weaned from ventilators and 7 (18.4%) underwent decannulation. Two patients (5.3%) expired in the weeks following tracheostomy. Between the 2 institutions, 10 attending surgeons performed all of the tracheostomies using appropriate personal protective equipment, and none demonstrated seroconversion within 1 to 2 weeks of this article.

COVID-19 patients in a tertiary US hospital: Assessment of clinical course and predictors of the disease severity.

INTRODUCTION: Patients with severe COVID-19 can develop ventilator-dependent acute hypoxic respiratory failure (VDAHRF), which is associated with a higher mortality rate. We evaluated the clinical course of hospitalized COVID-19 patients and compared them with the patients who received invasive mechanical ventilation. Characteristics of intubated patients who were successfully weaned from the ventilator were compared with the patients who failed to be extubated or died in the hospital. OBJECTIVE: To investigate the clinical course of hospitalized COVID-19 patients, and assess the possible predictors of the disease severity leading to VDAHRF. METHODS: This is a single-center, retrospective study. The first 129 patients (18 years or older) with COVID-19 admitted to Monmouth Medical Center from March 1st to April 25th, 2020 were included. RESULTS: Out of 129 patients, 23.25% (n = 30) required invasive mechanical ventilation, and of those, six patients were successfully weaned from the ventilator. Multivariable logistic regression analysis showed increased odds of intubation associated with hypoxemia (odds ratio 17.23, 95% CI 5.206-57.088; p < 0.0001), elevated d-dimer by one unit mg/L of FEU (odds ratio 1.515, 95% CI 5.206-57.088; p = 0.0430) and elevated ferritin by one unit ng/ml (odds ratio 1.001, 95% CI 1.000-1.001, p = 0.0051) on admission, adjusted for other covariates. CONCLUSIONS: Patients who required invasive mechanical ventilation were more likely to have older age, male gender, coronary artery disease, diabetes, and obesity. The patients who were successfully weaned from the ventilator were more likely to be younger in age, and none of them had heart failure or CAD.