NCT07186140尚未招募不适用
A Prospective Cohort Study to Explore Clinical Features, Prognosis, and Therapeutic Strategies in Patients With Acute Respiratory Distress Syndrome
Jee Hwan Ahn1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Ventilator-free days within 28 days
研究概览
简要总结
The goal of this observational prospective cohort study is to explore the clinical characteristics, treatment strategies, and outcomes of adult patients with acute respiratory distress syndrome (ARDS) admitted to the medical intensive care unit of Asan Medical Center. The main questions it aims to answer are:
- What are the clinical features, current practices, and prognosis of ARDS patients in Korea?
- How do different mechanical ventilation settings affect ARDS patient outcomes?
Participants will:
- Be screened at medical ICU admission for eligibility according to the Berlin definition of ARDS.
- Have demographic, clinical, laboratory, and ventilator data collected from bedside monitoring devices and electronic health records during their ICU stay.
- Complete a quality-of-life questionnaire (EQ-5D) at hospital discharge if they survive.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Receiving respiratory support with one of the following:
- •High-flow nasal oxygen (HFNO) at a flow rate ≥ 30 L/min,
- •Noninvasive ventilation (NIV) with positive end-expiratory pressure (PEEP) of ≥ 5 cm H₂O, or
- •Invasive mechanical ventilation with PEEP of ≥ 5 cm H₂O.
- •Within 48 hours before or after eligibility screening, the following criteria must be met:
- •PaO₂/FiO₂ ≤ 300 mmHg under the above respiratory support.
- •Bilateral opacities on chest radiograph or computed tomography, not fully explained by effusions, lobar/lung collapse (atelectasis), or pulmonary nodules/masses.
- •Respiratory failure not fully explained by cardiac failure or fluid overload; when no clear ARDS risk factor is identified, an objective assessment (e.g., echocardiography) is required to exclude hydrostatic edema.
排除标准
- •Refusal of informed consent by the patient or a legally authorized representative.
- •Chronic respiratory failure, defined as:
- •Patients receiving long-term oxygen therapy or home mechanical ventilation (except for CPAP used solely for obstructive sleep apnea), or
- •Outpatients with PaCO₂ > 60 mmHg.
- •Diffuse alveolar hemorrhage.
- •Interstitial lung disease.
- •Moribund patients expected to survive < 24 hours.
- •Patients expected to require high-flow nasal oxygen or mechanical ventilation for < 48 hours.
- •Patients with a decision to withhold life-sustaining treatment (except those for whom full support is provided other than cardiopulmonary resuscitation).
结局指标
主要结局
Ventilator-free days within 28 days
时间窗: From enrollment to Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment. Patients who die within 28 days will be assigned zero ventilator-free days.
次要结局
- Barotrauma(From enrollment until ICU discharge, up to 90 days)
- 28-day mortality(From enrollment to Day 28)
- 90-day mortality(From enrollment to Day 90)
- ICU mortality(From enrollment until ICU discharge, up to 90 days)
- Hospital mortality(From enrollment until hospital discharge, up to 90 days)
- Duration of invasive mechanical ventilation(From enrollment to Day 90)
- ICU length of stay(From enrollment until ICU discharge, up to 90 days)
- Hospital length of stay(From enrollment until hospital discharge, up to 90 days)
- Ventilator-associated pneumonia (VAP)(From enrollment until ICU discharge, up to 90 days)
- Central line-associated bloodstream infection (CLABSI)(From enrollment until ICU discharge, up to 90 days)
- Quality of life at hospital discharge(From enrollment until hospital discharge, up to 90 days)
- Disposition at hospital discharge(From enrollment until hospital discharge, up to 90 days)
研究者
Jee Hwan Ahn
Assistant Professor, University of Ulsan College of Medicine; Director, Medical ICU, Asan Medical Center
Asan Medical Center
研究点 (1)
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