Predicting ICU Admission and Death for COVID-19 Patients in the Emergency Department. Comparison of Five Scoring Systems.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 7-day ICU
研究概览
简要总结
INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Based on available data from 5% to 10% among hospitalized patients will require ICU admission.
In this context of overflow of critically ill patients, it is mandatory to establish clear and objective criteria to assess and predict a Covid-19 patient's need for ICU admission, and potentially predict death occurrence. Early Warning Scores (EWS) are used in hospitalized patients to predict clinical deterioration. Several study demonstrate the utility of EWS in ED to predict patient outcome.
AIM. The objective of this study is to evaluate five EWSs, to predict the need for ICU admission and the mortality in patients admitted in ED with COVID-19.
METHODS. This is a single-center, retrospective observational study. We will review the clinical records of all the patients consecutively admitted to our ED for Covid-19 over a three-weeks period (March 1 to 21, 2020). We will exclude from study cohort patients aged <18 years old and pregnant women, and patients already on oro-tracheal intubation at ED arrival. Based on clinical records five EWS will be calculated: NEWS, NEWS2, qSOFA, MEWS, REMS.
Study endpoints. The primary study endpoints will be death at 7 days, and need for ICU at 7 days, since ED admission. As secondary endpoints we will evaluate need for ICU and death at 24 and 48 hours since ED admission.
Statistical Analysis Receiver operating characteristic (ROC) curve analysis will be used to evaluate the overall performance of the selected EWSs in predicting the defined adverse outcomes. According to Youden's index we will estimate the optimal cut-off points and corresponding sensitivity and specificity at selected score threshold values. The comparison between the ROC AUCs will be made according to DeLong method.
详细描述
INTRODUCTION After the first cases identified in Wuhan city (China) on December 2019, the novel coronavirus designated SARS-CoV-2 has caused a global epidemic of respiratory illness named COVID-191. To date, more than, 3,000,000 cases have been reported worldwide, including more than 300,000 deaths.
Typical COVID-19 patients present with fever, myalgia or fatigue, and dry cough. Severe cases progress to severe dyspnoea and hypoxemia within one week after the onset of symptoms 3-5. In hospitalized COVID-19 patients, the prevalence of hypoxemic respiratory failure is around 20%, and more than 25% of them may require intensive care treatment.
The increasing number of COVID-19 cases has challenged the healthcare systems worldwide. Given the current overflow of critically ill patients in the Emergency Departments (EDs), an early identification of patients who need admittance to an intensive care unit (ICU) because of an increased risk of unfavourable outcome is necessary. Although general guidelines for ICU admission and triage exist, only limited guidance is available for the specific setting of COVID-19 patients.
In this context of overwhelming demand for medical assessment and triage in ED, early warning scores (EWS) may be useful. EWS are based on a rapid and quantitative assessment of changes in vital signs, and were developed to identify and track patients at risk of deterioration in non-critical areas of the hospital in order to ensure an early stabilisation and ICU transfer when appropriate and prevent avoidable cardiac arrest. However, in recent years these scores have been used in ED to predict ICU admission and mortality. Use of EWS has recently been proposed for the triage of COVID-19 patients in ED. However, their usefulness has not been demonstrated yet.
METHODS Study design This is a retrospective observational study conducted in the ED of the largest urban teaching hospital in Rome, a referral center for COVID-19 in central Italy. The participants reviewed the electronic medical records (EMR) of all adults (>18y) patients admitted to ED for suspected COVID-19 over three consecutive weeks from March 1 to March 21, 2020, tested for COVID-19 according to the WHO interim guidance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID 19 confirmed patients.
排除标准
- •<18 years
- •Pregnant women
- •Asymptomatic and normal x-ray findings subjects
结局指标
主要结局
7-day ICU
时间窗: 7 day
Admission to ICU by seven day from ED access
7-day death
时间窗: 7 day
Death by seven day from ED access
次要结局
未报告次要终点