NCT06967207招募中不适用
Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study
XiaoJing Zou,MD4 个研究点 分布在 1 个国家目标入组 625 人开始时间: 2025年4月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 625
- 试验地点
- 4
- 主要终点
- 28-day mortality rate
研究概览
简要总结
This multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the new 2023 ARDS global definition;
- •Age 18-80 years
排除标准
- •Expected death within 24 hours of screening;
- •Metastatic cancer (active malignancy with distant metastases);
- •Severe psychiatric disorders;
- •Pregnancy or postpartum status;
- •Pneumothorax or moderate to large pleural effusion without adequate drainage;
- •Chronic respiratory failure;
- •Patients with pulmonary embolism or pulmonary hypertension;
- •Heart failure patients: EF <50% or NYHA class III or IV;
- •Patient/family refusal to participate;
- •Participation in another interventional trial within 3 months prior to enrollment
结局指标
主要结局
28-day mortality rate
时间窗: From date of study enrollment (Day 0) until Day 28
次要结局
- ICU mortality rate(From ICU admission to discharge, up to 24 weeks)
- 60-day all-cause mortality rate(60 days post-enrollment)
- 90-day all-cause mortality rate(90 days post-enrollment)
- Duration of mechanical ventilation (days)(From intubation to successful extubation, up to 28 days)
- Ventilator-free days (VFDs) at 28 days(28 days post-enrollment)
- ICU length of stay (days)(From ICU admission to discharge, up to 24 weeks)
- Hospital length of stay(From hospital admission to discharge, up to 24 weeks)
研究者
XiaoJing Zou,MD
MD
Wuhan Union Hospital, China
研究点 (4)
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