A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,000
- 试验地点
- 1
- 主要终点
- Development of ARDS
研究概览
简要总结
We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.
Why?
The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:
- What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
- What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
- What is the incidence of ARDS based on the Berlin definition within this patient cohort?
- What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
- What is the natural history of ARDS?
- What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?
When?
The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.
What data is required?
A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.
详细描述
In summary, the study will focus on the following items:
-
The frequency and disease burden of acute hypoxaemic respiratory failure in winter
-
The aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support.
-
The incidence of ARDS based on the Berlin definition within this patient cohort
-
The mortality from ARDS within this cohort, and how does this vary based on ARDS severity
-
Natural history of ARDS (duration and evolution by severity)
-
Therapeutic resource utilization
-
Use of treatments, such as recruitment maneuvers, prone positioning, nitric oxide, high frequency oscillation, ECMO, transfer to tertiary hospital from smaller regional ones) according to the severity of the disease
-
Use of non-invasive ventilation in management of ARDS patients (use in different stages: early ARDS versus immediately after extubation).
This is a prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.
ICUs will be invited to participate on a voluntary basis. ICUs enrolling into existing databases (e.g., ERIC study, ICON audit) will be invited to participate. It is important that participating ICUs commit (by written agreement) to fully comply with the study protocol. ICU recruitment in each country will be spearheaded by a national coordinator Each ICU will be requested to recruit for 4 consecutive 'winter' weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the participating ICUs receiving invasive or non-invasive ventilation will be screened and included in the database.
排除标准
- •Age < 16
结局指标
主要结局
Development of ARDS
时间窗: 28 days
次要结局
- ICU mortality(28 days)