Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Southeast University, China
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 60-day mortality
概览
简要总结
Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure.
Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.
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
- •1.Age ≥ 18 years
- •Moderate-to-severe ARDS requiring invasive mechanical ventilation, defined as:
- •PaO₂/FiO₂ ≤ 150 mm Hg,
- •PEEP ≥ 5 cm H₂O,
- •ARDS diagnosed according to the 2023 Global Definition.
排除标准
- •1.Refusal of informed consent by the patient's legally authorized representative
结局指标
主要结局
60-day mortality
时间窗: From inclusion to 28 days
The proportion of patients who are died within 60 days
次要结局
- 28-day mortality(From inclusion to 28 days)
- Ventilator-free days at 28 days(From inclusion to 28 days)
研究者
Ling Liu
Professor
Southeast University, China