Purpose
To describe critical care patients with COVID-19 across England, Wales and Northern Ireland and compare them with a historic cohort of patients with other viral pneumonias (non-COVID-19) and ...with international cohorts of COVID-19.
Methods
Extracted data on patient characteristics, acute illness severity, organ support and outcomes from the Case Mix Programme, the national clinical audit for adult critical care, for a prospective cohort of patients with COVID-19 (February to August 2020) are compared with a recent retrospective cohort of patients with other viral pneumonias (non-COVID-19) (2017–2019) and with other international cohorts of critical care patients with COVID-19, the latter identified from published reports.
Results
10,834 patients with COVID-19 (70.1% male, median age 60 years, 32.6% non-white ethnicity, 39.4% obese, 8.2% at least one serious comorbidity) were admitted across 289 critical care units. Of these, 36.9% had a PaO
2
/FiO
2
ratio of ≤ 13.3 kPa (≤ 100 mmHg) consistent with severe ARDS and 72% received invasive ventilation. Acute hospital mortality was 42%, higher than for 5782 critical care patients with other viral pneumonias (non-COVID-19) (24.7%), and most COVID-19 deaths (88.7%) occurred before 30 days. Meaningful international comparisons were limited due to lack of standardised reporting.
Conclusion
Critical care patients with COVID-19 were disproportionately non-white, from more deprived areas and more likely to be male and obese. Conventional severity scoring appeared not to adequately reflect their acute severity, with the distribution across PaO
2
/FiO
2
ratio categories indicating acutely severe respiratory disease. Critical care patients with COVID-19 experience high mortality and place a great burden on critical care services.
Abstract
Background
The FIRST-ABC trial comprises of two pragmatic, multicentre, parallel groups, non-inferiority randomised clinical trials designed to evaluate the clinical non-inferiority of ...first-line use of high flow nasal cannula (HFNC) to continuous positive airway pressure (CPAP) in critically ill children who require non-invasive respiratory support (NRS).
Objectives
To describe the pre-specified statistical and health economic analysis for the FIRST-ABC trial before completion of patient recruitment and data collection.
Methods
The statistical analysis plan was designed by the chief investigators and statisticians. We define the primary and secondary outcomes, summarise methods for data collection and safety monitoring, and present a detailed description of the planned statistical and health economic analysis.
Results
The primary clinical outcome is time to liberation from respiratory support. The primary effect estimate will be the adjusted hazard ratio, reported with a 95% confidence interval. As a sensitivity analysis, the primary analysis will be repeated using time to start weaning of NRS. Subgroup analyses will be performed to test for interactions between the effect of allocated treatment group and pre-specified baseline covariates. The health economic analysis will follow the intention-to-treat principle and report the mean (95% confidence interval) incremental costs, quality-adjusted life years (QALYs) and cost-effectiveness up to 6 months. All analyses will be performed separately for each of the two trials, and any results will not be combined.
Conclusion
The FIRST-ABC trial will assess the non-inferiority of HFNC compared to CPAP in two parallel trials with shared infrastructure (step-up RCT and step-down RCT). We have developed a pre-specified statistical and health economics analysis plan for the FIRST-ABC study before trial completion to minimise analytical bias.
Trial registration
ISRCTN
ISRCTN60048867
. Registered on 19 June 2019.
To report the patient characteristics and clinical outcome of paediatric in-hospital cardiac arrest in the United Kingdom (UK) National Cardiac Arrest Audit (NCAA) database.
Analysis of all recorded ...paediatric cardiac arrests in the NCAA dataset over a seven-year period ending on 31 December 2018, within acute children’s hospitals (including standalone paediatric hospitals and hospitals with tertiary paediatric services) and acute general hospitals participating in NCAA. In this period 1456 patients (with 1580 events), 1 month to 16 years of age, received chest compressions and/or defibrillation and were attended by a hospital-based resuscitation team in response to an emergency call. The main outcome measure was survival to discharge.
For this cohort of paediatric in-hospital cardiac arrest patients the overall rates of sustained return of spontaneous circulation (ROSC) were 69.1% with unadjusted survival to hospital discharge of 54.2%. The presenting rhythm was shockable in 4.3% of events and non-shockable in 82.1% (remainder undetermined); rates of survival to hospital discharge associated with these rhythms were 63.9% and 51.7%. A difference in outcomes was observed between Children’s hospitals and acute general hospitals with ROSC rates of 79.1% and 55.5% respectively and survival to hospital discharge rates of 57.7% and 49.3% respectively.
These first results from the NCAA database describing the outcome of paediatric in-hospital cardiac arrest in UK hospitals will serve as a benchmark from which to assess the future impact of changes in service delivery, organisation and treatment for in-hospital cardiac arrest in young people. Outcomes for specialist paediatric centres should be studied further as higher rates of ROSC and survival to hospital discharge were observed.
Patients undergoing lung resection are at risk of perioperative complications, many of which necessitate unplanned critical care unit admission in the postoperative period. We sought to characterize ...this population, providing an up-to-date estimate of the incidence of unplanned critical care admission, and to assess critical care and hospital stay, resource use, mortality, and outcomes.
A multicenter retrospective cohort study of patients undergoing lung resection in participating UK hospitals over 2 years. A comprehensive dataset was recorded for each critical care admission (defined as the need for intubation and mechanical ventilation and/or renal replacement therapy), in addition to a simplified dataset in all patients undergoing lung resection during the study period. Multivariable regression analysis was used to identify factors independently associated with critical care outcome.
A total of 11,208 patients underwent lung resection in 16 collaborating centers during the study period, and 253 patients (2.3%) required unplanned critical care admission with a median duration of stay of 13 (4-28) days. The predominant indication for admission was respiratory failure (68.1%), with 77.8% of patients admitted during the first 7 days following surgery. Eighty-seven (34.4%) died in critical care. On multivariable regression, only the diagnosis of right ventricular dysfunction and the need for both mechanical ventilation and renal-replacement therapy were independently associated with critical care survival; this model, however, had poor predictive value.
Although resource-intensive and subject to prolonged stay, following unplanned admission to critical care after lung resection outcomes are good for many patients; 65.6% of patients survived to hospital discharge, and 62.7% were discharged to their own home.
Resource use, outcomes, and implications of unplanned critical care admission after lung resection. Display omitted
IMPORTANCE: The optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known. OBJECTIVE: To evaluate the noninferiority of high-flow nasal ...cannula (HFNC) therapy as the first-line mode of noninvasive respiratory support following extubation, compared with continuous positive airway pressure (CPAP), on time to liberation from respiratory support. DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive respiratory support within 72 hours of extubation were recruited between August 8, 2019, and May 18, 2020, with last follow-up completed on November 22, 2020. INTERVENTIONS: Patients were randomized 1:1 to start either HFNC at a flow rate based on patient weight (n = 299) or CPAP of 7 to 8 cm H2O (n = 301). MAIN OUTCOMES AND MEASURES: The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were 6 secondary outcomes, including mortality at day 180 and reintubation within 48 hours. RESULTS: Of the 600 children who were randomized, 553 children (HFNC, 281; CPAP, 272) were included in the primary analysis (median age, 3 months; 241 girls 44%). HFNC failed to meet noninferiority, with a median time to liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) for CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞). Similar results were seen across prespecified subgroups. Of the 6 prespecified secondary outcomes, 5 showed no significant difference, including the rate of reintubation within 48 hours (13.3% for HFNC vs 11.5 % for CPAP). Mortality at day 180 was significantly higher for HFNC (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 95% CI, 1.1-8.8). The most common adverse events were abdominal distension (HFNC: 8/281 2.8% vs CPAP: 7/272 2.6%) and nasal/facial trauma (HFNC: 14/281 5.0% vs CPAP: 15/272 5.5%). CONCLUSIONS AND RELEVANCE: Among critically ill children requiring noninvasive respiratory support following extubation, HFNC compared with CPAP following extubation failed to meet the criterion for noninferiority for time to liberation from respiratory support. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN60048867
IMPORTANCE: The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known. OBJECTIVE: To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) ...as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022. INTERVENTIONS: Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n = 301) or CPAP of 7 to 8 cm H2O (n = 299). MAIN OUTCOMES AND MEASURES: The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation. RESULTS: Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls 39%). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours 95% CI –10.1 to 17.4 hours; adjusted hazard ratio 1.03 1-sided 97.5% CI, 0.86-∞). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 95% CI, 0.39-0.88); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, −3 days 95% CI, −5.1 to −1 days); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, −7.6 days 95% CI, −13.2 to −1.9 days). The most common adverse event was nasal trauma (HFNC: 6/295 2.0%; CPAP: 18/278 6.5%). CONCLUSIONS AND RELEVANCE: Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support. TRIAL REGISTRATION: ISRCTN.org Identifier: ISRCTN60048867
Background
Early in a pandemic, outcomes are biased towards patients with shorter durations of critical illness. We describe 60-day outcomes for patients critically ill with confirmed COVID-19 and ...explore the potential bias in the weekly reported data by ICNARC.
Methods
First 200 consecutive patients with confirmed COVID-19, admitted for critical care in England, Wales and Northern Ireland, followed-up for a minimum of 60 days from admission. Outcomes included survival and duration of critical care, receipt/duration of organ support in critical care and hospital survival.
Results
Mean age was 62.6 years, 70.5% were male, 52.0% were white, 39.2% obese and 9.0% had serious comorbidities. Median APACHE II score was 16 (IQR 12, 19). After 60 days, 83 (41.5%) patients had been discharged from hospital, 15 (7.5%) had been discharged from critical care but remained in hospital, 1 (0.5%) was still receiving critical care, 90 (45.0%) had died while receiving critical care and 11 (5.5%) had died in hospital after discharge from critical care. Median duration of critical care was 14.0 days (IQR 6.1, 23.0) for survivors and 10.0 days (IQR 5.0, 16.0) for non-survivors of critical care. Overall, 158 (79.0%) patients received advanced respiratory support for a median of 13 (IQR 8, 20) calendar days. Compared with weekly reports during the pandemic, critical care mortality started higher than but then decreased below that of the first 200 consecutive patients. Duration of critical care, for both survivors and non-survivors increased over time; however, both were still lower than those for the first 200 consecutive patients. Receipt and duration of organ support increased to values similar to those for the first 200 consecutive patients.
Conclusion
COVID-19 in critical care has high mortality and places a large burden on resources. Analysis of preliminary data with limited follow-up should be interpreted with caution, particularly for future planning in a pandemic.
Objective(s): Patients undergoing lung resection are at risk of perioperative complications, many of which necessitate unplanned critical care unit admission in the postoperative period. We sought to ...characterize this population, providing an up-to-date estimate of the incidence of unplanned critical care admission, and to assess critical care and hospital stay, resource use, mortality, and outcomes. Methods: A multicenter retrospective cohort study of patients undergoing lung resection in participating UK hospitals over 2 years. A comprehensive dataset was recorded for each critical care admission (defined as the need for intubation and mechanical ventilation and/or renal replacement therapy), in addition to a simplified dataset in all patients undergoing lung resection during the study period. Multivariable regression analysis was used to identify factors independently associated with critical care outcome. Results: A total of 11,208 patients underwent lung resection in 16 collaborating centers during the study period, and 253 patients (2.3%) required unplanned critical care admission with a median duration of stay of 13 (4-28) days. The predominant indication for admission was respiratory failure (68.1%), with 77.8% of patients admitted during the first 7 days following surgery. Eighty-seven (34.4%) died in critical care. On multivariable regression, only the diagnosis of right ventricular dysfunction and the need for both mechanical ventilation and renal-replacement therapy were independently associated with critical care survival; this model, however, had poor predictive value. Conclusions: Although resource-intensive and subject to prolonged stay, following unplanned admission to critical care after lung resection outcomes are good for many patients; 65.6% of patients survived to hospital discharge, and 62.7% were discharged to their own home.
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