CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 325
- 主要终点
- Rate of failure of non-invasive respiratory support
研究概览
简要总结
This observational study aims to evaluate the relationship between clinical and physiological variables and the failure of non-invasive respiratory support (NIRS), including high-flow nasal oxygen (HFNO) and non-invasive ventilation (NIV), in patients with acute respiratory failure (ARF), both hypoxemic and/or hypercapnic. The study includes both retrospective and prospective components. Retrospective data will be collected from patient charts, while prospective data will be collected at defined time points during clinical care. The primary outcome is NIRS failure, defined as the need for orotracheal intubation. Secondary outcomes include in-hospital and 90-day mortality, ICU and hospital length of stay, and duration of non-invasive and invasive support.
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
- •Hospitalization in the Respiratory Medicine Unit at AOU Policlinico di Modena
- •Acute respiratory failure (hypoxemic and/or hypercapnic) with PaO₂/FiO₂ < 300 mmHg
- •Undergoing treatment with HFNO or NIV
排除标准
- •Immediate need for invasive ventilation upon admission
- •Known neuromuscular disease
- •Pregnancy
- •Lack of informed consent
结局指标
主要结局
Rate of failure of non-invasive respiratory support
时间窗: 30 days
Number of patients experiencing NIRS failure (defined as escalation to another NIRS modality, need for orotracheal intubation, or death) over the total number of patients.
次要结局
- Clinical impact(From enrollment to 90 days)
研究者
Roberto Tonelli
Assistant Professor
University of Modena and Reggio Emilia