Respiratory Supports and COVID-19 Mortality: a One-year Cohort Study Across a Health Care System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- rate of in-hospital mortality
研究概览
简要总结
Critically ill COVID-19 patients have a relatively high mortality rate (~30%). Most critically ill COVID-19 patients require respiratory supports. The respiratory supports used in this patient population included conventional oxygen therapy (COT) via nasal cannula or face mask, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). NIV has three different methods, including high-flow nasal cannula (HFNC), bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP). There are outstanding questions that remain to be answered. One is which NIV is more effective; the other is if the use of IMV leads to increased mortality. Another relevant question is if ventilator settings (such as tidal volume, drive pressure, and positive end-expiratory pressure) are associated with different mechanical ventilated patients' outcomes. To answer these questions, a retrospective cohort study based on all patients who had been treated in the ICUs in Yale New Haven Health System throughout the first pandemic year was designed.
详细描述
Statistical methods
Continuous data are presented as mean and standard deviation (SD) if it follows a normal distribution assessed using histograms and Q-Q plots; otherwise, as median and interquartile range (IQR). Categorical data are presented as numbers and percentages. Missing data will not be imputed. Patients from a specific analysis were excluded if the data for the related variable are missing.
The first objective is to investigate the relative effectiveness of different NIVs, including high-flow nasal cannula (HFNC), bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP). Patients will be divided into three groups per the type of NIV they first received. Patients who received invasive mechanical ventilation (IMV) before NIV will be excluded. Patients who received two or three different types of NIV will also be excluded in this analysis. Patients who received IMV after the use of NIV are eligible.
The secondary objective is to investigate the impact of IMV on mortality via comparison with patients who received NIV only. The role of lung protective ventilation in patients who received IMV will also be investigated. The characteristics of the ventilator settings that are associated with an improved outcome will be explored.
The primary outcome is in-hospital mortality and patients will be followed until hospital discharge. Patients are considered alive if they were discharged alive from the hospital or are still hospitalized at the closure of data extraction. For the first objective, the rate of respiratory support escalation from NIV to IMV will also be analyzed (as a secondary outcome measure in this analysis).
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
- •All COVID-19 patients treated in the ICUs in Yale New Haven Health System throughout the first pandemic year
排除标准
- 未提供
结局指标
主要结局
rate of in-hospital mortality
时间窗: through study completion, an average of 11 days
the number of all-cause death during hospitalization divided by the number of patients who were discharged from hospital or remained hospitalized but alive on the last day of data extraction
次要结局
- rate of escalation from non-invasive ventilation to invasive mechanical ventilation(through study completion, an average of 11 days)