NCT06680895招募中不适用
An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- FeNO concentration
研究概览
简要总结
-
Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.
-
Secondary Purpose:
-
To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;
-
The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
-
Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
- •The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
- •The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;
- •Agree to participate in this experiment and sign the informed consent.
排除标准
- •1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement;
- •Participating in other clinical research projects;
- •Patients deemed unsuitable by the investigators.
结局指标
主要结局
FeNO concentration
时间窗: 1.5 year
Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU
次要结局
未报告次要终点
研究者
研究点 (1)
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