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临床试验/NCT07284888
NCT07284888
招募中
不适用

Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study

Southeast University, China1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年1月1日最近更新:

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

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

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Professor

Southeast University, China

研究点 (1)

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