International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 90 days in-hospital mortality
研究概览
简要总结
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. This survey aims to prospectively collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure. This study also aims to identify predictive factors strongly associated with extubation failure. The contents of mechanical ventilation settings, respiratory conditions, and blood examination data will be collected.
详细描述
1.1. Background
Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by widespread inflammatory lung injury, and is encountered in an estimated 23% of mechanically ventilated patients (1). Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40% (1), which implies that better management strategies for them are needed to improve the outcomes.
In the management for the mechanical ventilated patients with ARDS, the timing and judgement for extubation is clinically important, because extubation failure can be associated with worse outcome (2). The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure, but they are mainly based on the studies for patients with acute respiratory failure (3), and there is no study focusing on the patients with ARDS. Considering that the best method to extubate successfully has not been determined, the clinical management at the timing of extubation can be varied by each institution or each country, and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed.
1.2. Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt. This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS.
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
- •Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
- •Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS.
排除标准
- •Patients who already had tracheostomy at the start of invasive mechanical ventilation
- •Patients who were transferred to participating hospital more than 2 days after the start of invasive mechanical ventilation
- •Patients with terminal conditions at the start of invasive mechanical ventilation
- •Patients who have expressed their refusal to have their clinical data used in research
结局指标
主要结局
90 days in-hospital mortality
时间窗: From intubation to 90 days after intubation
90 days in-hospital mortality
occurrence of re-intubation event
时间窗: From extubation until the hospital discharge, assessed up to 24 months
occurrence of re-intubation event
次要结局
未报告次要终点
研究者
Mitsuaki Nishikimi
Assistant Professor Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University
Hiroshima University