NCT06867237尚未招募不适用
The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on the Outcomes of Mechanically Ventilated Patients With High Risk of Aspiration: a Single-center, Prospective, Randomized Controlled Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 90 人开始时间: 2025年3月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- The number of days free from VALRTI within 28 days.
研究概览
简要总结
Assessing the effectiveness of continuous cuff pressure management combined with subglottic suction irrigation in reducing ventilator-associated lower respiratory tract infections (VALRTI) in mechanically ventilated patients at high risk of aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years;
- •Undergoing endotracheal intubation or tracheostomy;
- •Expected duration of mechanical ventilation exceeding 72 hours;
- •Presence of one or more high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new or pre-existing swallowing dysfunction), cranial surgery/traumatic brain injury (TBI), neuromuscular junction disorders (e.g., myasthenia gravis, muscular dystrophy, Parkinson's disease, or other conditions that weaken swallowing muscle strength and coordination), continuous use of muscle relaxants for ≥ 48 hours during mechanical ventilation, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume > 500 mL/6 hours), or impaired consciousness;
- •Voluntary participation in the study by the subject or their legal representative, with signed informed consent.
排除标准
- •Expected duration of mechanical ventilation less than 48 hours;
- •Pregnant or breastfeeding women;
- •Patients with tracheoesophageal or bronchopleural fistula;
- •Difficult intubation (more than three attempts) or patients with reflux/aspiration during intubation (with lung injury and secondary pulmonary infection);
- •Patients with irreversible disease, end-stage conditions, or those expected to die in the near future;
- •Patients already diagnosed with ventilator-associated pneumonia (VAP), i.e., excluding hospital-acquired pneumonia;
- •Patients participating in other clinical trials that are expected to influence the results of this study;
- •Patients deemed unsuitable for inclusion in the study by the investigator.
结局指标
主要结局
The number of days free from VALRTI within 28 days.
时间窗: 28 days
The number of days free from ventilator-associated lower respiratory tract infection (VALRTI) within 28 days.
次要结局
未报告次要终点
研究者
Ming Zhong
Doctor
Shanghai Zhongshan Hospital
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