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1.
Chest ; 2022 Apr 30.
Article in English | MEDLINE | ID: covidwho-1814242

ABSTRACT

Mortality historically has been the primary outcome of choice for acute and critical care clinical trials. However, undue reliance on mortality can limit the scope of trials that can be performed. Large sample sizes usually are needed for trials powered for a mortality outcome, and focusing solely on mortality fails to recognize the importance that reducing morbidity can have on patients' lives. The COVID-19 pandemic has highlighted the need for rapid, efficient trials to evaluate new therapies rigorously for hospitalized patients with acute lung injury. Oxygen-free days (OFDs) are a novel outcome for clinical trials that is a composite of mortality and duration of new supplemental oxygen use. It is designed to characterize recovery from acute lung injury in populations with a high prevalence of new hypoxemia and supplemental oxygen use. In these populations, OFDs capture two patient-centered consequences of acute lung injury: mortality and hypoxemic lung dysfunction. Power to detect differences in OFDs typically is greater than that for other clinical trial outcomes, such as mortality and ventilator-free days. OFDs are the primary outcome for the Fourth Accelerating COVID-19 Therapeutic Interventions and Vaccines Host Tissue platform, which evaluates novel therapies targeting the host response to COVID-19 among adults hospitalized with COVID-19 and new hypoxemia. This article outlines the rationale for use of OFDs as an outcome for clinical trials, proposes a standardized method for defining and analyzing OFDs, and provides a framework for sample size calculations using the OFD outcome.

2.
Dimens Crit Care Nurs ; 40(6): 321-327, 2021.
Article in English | MEDLINE | ID: covidwho-1450455

ABSTRACT

BACKGROUND: Prone positioning has been used as an intervention to improve oxygenation in critically ill patients with acute respiratory distress syndrome. During the COVID-19 pandemic, resources were even more limited given a surge in acute respiratory distress syndrome patients, which outstripped intensive care unit (ICU) capacity at many institutions. LOCAL PROBLEM: The purpose of this article is to describe the development and implementation of a proning team during the surge in ICU patients with COVID-19 and to measure the impact of the program through surveys of staff involved. METHODS/INTERVENTIONS: A proning protocol and educational plan was developed. A proning team of redeployed staff was created. A survey of ICU registered nurses and proning team members was used to evaluate the benefits and challenges of the proning team. RESULTS: The proning team was successful in safely performing more than 300 proning and supinating maneuvers for critically ill patients. There is overwhelming support within the institution for a proning team for future COVID-19 surges. DISCUSSION: The development and implementation of the proning team happened quickly to assist with the surge of patients and off-load work from ICU registered nurses. Despite the success of the proning team, more clearly defined roles and expectations, as well as additional education, are needed to further enhance teamwork and workflow. CONCLUSIONS: Creation of the proning team was a creative use of resources that helped manage the large and medically complex patient population. This work may serve as a guide to other health care institutions.


Subject(s)
COVID-19 , Pandemics , Humans , Intensive Care Units , Prone Position , SARS-CoV-2
3.
Intern Emerg Med ; 17(2): 359-367, 2022 03.
Article in English | MEDLINE | ID: covidwho-1270539

ABSTRACT

The relationship between COVID-19 severity and viral load is unknown. Our objective was to assess the association between viral load and disease severity in COVID-19. In this single center observational study of adults with laboratory confirmed SARS-CoV-2, the first positive in-hospital nasopharyngeal swab was used to calculate the log10 copies/ml [log10 copy number (CN)] of SARS-CoV-2. Four categories based on level of care and modified sequential organ failure assessment score (mSOFA) at time of swab were determined. Median log10CN was compared between different levels of care and mSOFA quartiles. Median log10CN was compared in patients who did and did not receive influenza vaccine, and the correlation between log10CN and D-dimer was examined. We found that of 396 patients, 54.3% were male, and 25% had no major comorbidity. Hospital mortality was 15.7%. Median mSOFA was 2 (IQR 0-3). Median log10CN was 5.5 (IQR 3.3-8.0). Median log10CN was highest in non-intubated ICU patients [6.4 (IQR 4.4-8.1)] and lowest in intubated ICU patients [3.6 (IQR 2.6-6.9)] (p value < 0.01). In adjusted analyses, this difference remained significant [mean difference 1.16 (95% CI 0.18-2.14)]. There was no significant difference in log10CN between other groups in the remaining pairwise comparisons. There was no association between median log10CN and mSOFA in either unadjusted or adjusted analyses or between median log10CN in patients with and without influenza immunization. There was no correlation between log10CN and D-dimer. We conclude, in our cohort, we did not find a clear association between viral load and disease severity in COVID-19 patients. Though viral load was higher in non-intubated ICU patients than in intubated ICU patients there were no other significant differences in viral load by disease severity.


Subject(s)
COVID-19 , Adult , Hospital Mortality , Humans , Male , SARS-CoV-2 , Severity of Illness Index , Viral Load
4.
Resusc Plus ; 6: 100121, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1179992

ABSTRACT

BACKGROUND: Management of patients with acute deterioration from novel coronavirus disease of 2019 (COVID-19) has posed a particular challenge for rapid response systems (RRSs) due to increased hospital strain and direct risk of infection to RRS team members. OBJECTIVE: We sought to characterize RRS structure and protocols adaptions during the COVID-19 pandemic. DESIGN SETTING AND PARTICIPANTS: Internet-based cross-sectional survey of RRS leaders, physicians, and researchers across the United States. RESULTS: Clinicians from 46 hospitals were surveyed, 40 completed a baseline survey (87%), and 19 also completed a follow-up qualitative survey. Most reported an increase in emergency team resources during the COVID-19 pandemic. The number of sites performing simulation training sessions decreased from 88% before COVID-19 to 53% during the pandemic. CONCLUSIONS: Most RRSs reported pandemic-related adjustments, most commonly through increasing resources and implementation of protocol changes. There was a reduction in the number of sites that performed simulation training.

5.
J Gen Intern Med ; 36(6): 1689-1695, 2021 06.
Article in English | MEDLINE | ID: covidwho-1141487

ABSTRACT

BACKGROUND: Widespread reports suggest the characteristics and disease course of coronavirus disease 2019 (COVID-19) and influenza differ, yet detailed comparisons of their clinical manifestations are lacking. OBJECTIVE: Comparison of the epidemiology and clinical characteristics of COVID-19 patients during the pandemic with those of influenza patients in previous influenza seasons at the same hospital DESIGN: Admission rates, clinical measurements, and clinical outcomes from confirmed COVID-19 cases between March 1 and April 30, 2020, were compared with those from confirmed influenza cases in the previous five influenza seasons (8 months each) beginning September 1, 2014. SETTING: Large tertiary care teaching hospital in Boston, MA PARTICIPANTS: Laboratory-confirmed COVID-19 and influenza inpatients MEASUREMENTS: Patient demographics and medical history, mortality, incidence and duration of mechanical ventilation, incidences of vasopressor support and renal replacement therapy, and hospital and intensive care admissions. RESULTS: Data was abstracted from medical records of 1052 influenza patients and 582 COVID-19 patients. An average of 210 hospital admissions for influenza occurred per 8-month season compared to 582 COVID-19 admissions over 2 months. The median weekly number of COVID-19 patients requiring mechanical ventilation was 17 (IQR: 4, 34) compared to a weekly median of 1 (IQR: 0, 2) influenza patient (p=0.001). COVID-19 patients were significantly more likely to require mechanical ventilation (31% vs 8%) and had significantly higher mortality (20% vs. 3%; p<0.001 for all). Relatively more COVID-19 patients on mechanical ventilation lacked pre-existing conditions compared with mechanically ventilated influenza patients (25% vs 4%, p<0.001). Pneumonia/ARDS secondary to the virus was the predominant cause of mechanical ventilation in COVID-19 patients (94%) as opposed to influenza (56%). LIMITATION: This is a single-center study which could limit generalization. CONCLUSION: COVID-19 resulted in more weekly hospitalizations, higher morbidity, and higher mortality than influenza at the same hospital.


Subject(s)
COVID-19 , Influenza, Human , Hospitalization , Humans , Influenza, Human/epidemiology , Influenza, Human/therapy , Pandemics , SARS-CoV-2 , Tertiary Care Centers
7.
J Crit Care ; 63: 106-112, 2021 06.
Article in English | MEDLINE | ID: covidwho-1101349

ABSTRACT

PURPOSE: Acute Respiratory Distress Syndrome (ARDS) secondary to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has demonstrated variable oxygenation and respiratory-system mechanics without investigation of transpulmonary and chest-wall mechanics. This study describes lung, chest wall and respiratory-system mechanics in patients with SARS-CoV-2 and ARDS. METHODS: Data was collected from forty patients with confirmed SARS-CoV-2 and ARDS at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Esophageal balloons were placed to estimate pleural and transpulmonary pressures. Clinical characteristics, respiratory-system, transpulmonary, and chest-wall mechanics were measured over the first week. RESULTS: Patients had moderate-severe ARDS (PaO2/FiO2 123[98-149]) and were critically ill (APACHE IV 108 [94-128] and SOFA 12 [11-13]). PaO2/FiO2 improved over the first week (150 mmHg [122.9-182] to 185 mmHg [138-228] (p = 0.035)). Respiratory system (30-35 ml/cm H2O), lung (40-50 ml/cm H2O) and chest wall (120-150 ml/cm H2O) compliance remained similar over the first week. Elevated basal pleural pressures correlated with BMI. Patients required prolonged mechanical ventilation (14.5 days [9.5-19.0]), with a mortality of 32.5%. CONCLUSIONS: Patients displayed normal chest-wall mechanics, with increased basal pleural pressure. Respiratory system and lung mechanics were similar to known existing ARDS cohorts. The wide range of respiratory system mechanics illustrates the inherent heterogeneity that is consistent with typical ARDS.


Subject(s)
COVID-19/complications , Lung/physiopathology , Respiratory Distress Syndrome/etiology , Respiratory Mechanics , SARS-CoV-2/genetics , APACHE , Aged , Boston/epidemiology , COVID-19/epidemiology , COVID-19/therapy , COVID-19/virology , Cohort Studies , Critical Illness , Female , Humans , Male , Middle Aged , Organ Dysfunction Scores , Positive-Pressure Respiration/methods , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/therapy , Respiratory Distress Syndrome/virology
8.
Resuscitation ; 160: 72-78, 2021 03.
Article in English | MEDLINE | ID: covidwho-1051928

ABSTRACT

BACKGROUND: Coronavirus Disease 2019 (COVID-19) has caused over 1 200 000 deaths worldwide as of November 2020. However, little is known about the clinical outcomes among hospitalized patients with active COVID-19 after in-hospital cardiac arrest (IHCA). AIM: We aimed to characterize outcomes from IHCA in patients with COVID-19 and to identify patient- and hospital-level variables associated with 30-day survival. METHODS: We conducted a multicentre retrospective cohort study across 11 academic medical centres in the U.S. Adult patients who received cardiopulmonary resuscitation and/or defibrillation for IHCA between March 1, 2020 and May 31, 2020 who had a documented positive test for Severe Acute Respiratory Syndrome Coronavirus 2 were included. The primary outcome was 30-day survival after IHCA. RESULTS: There were 260 IHCAs among COVID-19 patients during the study period. The median age was 69 years (interquartile range 60-77), 71.5% were male, 49.6% were White, 16.9% were Black, and 16.2% were Hispanic. The most common presenting rhythms were pulseless electrical activity (45.0%) and asystole (44.6%). ROSC occurred in 58 patients (22.3%), 31 (11.9%) survived to hospital discharge, and 32 (12.3%) survived to 30 days. Rates of ROSC and 30-day survival in the two hospitals with the highest volume of IHCA over the study period compared to the remaining hospitals were considerably lower (10.8% vs. 64.3% and 5.9% vs. 35.7% respectively, p < 0.001 for both). CONCLUSIONS: We found rates of ROSC and 30-day survival of 22.3% and 12.3% respectively. There were large variations in centre-level outcomes, which may explain the poor survival in prior studies.


Subject(s)
COVID-19/complications , COVID-19/mortality , Heart Arrest/mortality , Heart Arrest/virology , Hospitalization , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Survival Rate , United States
9.
Eur Respir Rev ; 29(157)2020 Sep 30.
Article in English | MEDLINE | ID: covidwho-835811

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a disease caused by severe acute respiratory syndrome-coronavirus-2. Consensus suggestions can standardise care, thereby improving outcomes and facilitating future research. METHODS: An International Task Force was composed and agreement regarding courses of action was measured using the Convergence of Opinion on Recommendations and Evidence (CORE) process. 70% agreement was necessary to make a consensus suggestion. RESULTS: The Task Force made consensus suggestions to treat patients with acute COVID-19 pneumonia with remdesivir and dexamethasone but suggested against hydroxychloroquine except in the context of a clinical trial; these are revisions of prior suggestions resulting from the interim publication of several randomised trials. It also suggested that COVID-19 patients with a venous thromboembolic event be treated with therapeutic anticoagulant therapy for 3 months. The Task Force was unable to reach sufficient agreement to yield consensus suggestions for the post-hospital care of COVID-19 survivors. The Task Force fell one vote shy of suggesting routine screening for depression, anxiety and post-traumatic stress disorder. CONCLUSIONS: The Task Force addressed questions related to pharmacotherapy in patients with COVID-19 and the post-hospital care of survivors, yielding several consensus suggestions. Management options for which there is insufficient agreement to formulate a suggestion represent research priorities.


Subject(s)
Advisory Committees/organization & administration , Betacoronavirus , Consensus , Coronavirus Infections/epidemiology , International Cooperation , Pneumonia, Viral/epidemiology , Pulmonary Medicine/standards , Societies, Medical , COVID-19 , Europe , Humans , Pandemics , SARS-CoV-2 , United States
12.
Am J Respir Crit Care Med ; 201(12): 1560-1564, 2020 06 15.
Article in English | MEDLINE | ID: covidwho-155108
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