A Randomized Controlled Trial of Infection-site-targeted Postural Drainage Combined With Mechanical Vibration for Mechanically Ventilated ICU Patients With Pulmonary Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
This single-center, 1:1 randomized controlled trial aimed to evaluate the efficacy of infection-site-targeted postural drainage combined with mechanical vibration for mechanically ventilated ICU patients with pulmonary infection.
Eligible subjects were randomly assigned to either the personalized-care group (PCG, intervention) or routine-care group (RCG, control).
Patients in PCG received imaging-guided infection-site-targeted postural drainage plus mechanical vibration. Patients in RCG received standard routine position changes and mechanical vibration without imaging-guided targeted positional adjustment.
The primary outcome was duration of invasive mechanical ventilation. Secondary outcomes included PaO₂/FiO₂ ratio, ICU length of stay, total hospital length of stay, and 28-day all-cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Aged 18-80 years old;
- •Admitted to ICU and receiving invasive mechanical ventilation;
- •Clinically confirmed pulmonary infection;
- •Enrolled between May 2022 and October 2024.
排除标准
- •Unstable systemic disease contraindicating postural changes;
- •Active bleeding (gastrointestinal, intracranial, or pulmonary);
- •Requirement for continuous renal replacement therapy;
- •Raised intracranial pressure;
- •Neuromuscular disorder;
- •Multiple fractures or major trauma;
- •Severe hemodynamic instability;
- •Significant arrhythmias;
- •Severe delirium or altered mental status;
- •Pregnancy or lactation;
- •Currently participating in another interventional clinical trial.
研究组 & 干预措施
Intervention group
干预措施: Imaging-guided infection-site-targeted postural drainage plus mechanical vibration chest physiotherapy. (Procedure)
Routine-care group
干预措施: Routine position change combined with mechanical vibration (Procedure)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: From initiation of invasive mechanical ventilation until successful extubation or death, assessed up to day 28.
次要结局
- ICU length of stay(From randomization until ICU discharge, assessed up to 28 calendar days from randomization)
- 28-day mortality(All-cause mortality assessed at 28 calendar days from the date of randomization)
- Total hospital length of stay(From randomization until hospital discharge, assessed up to 28 calendar days from randomization)
- PaO₂/FiO₂ ratio(Measured at baseline (X1), Day 1, Day 2, Day 3, Day 4 post-randomization (X2-X4), and at weaning preparation (X5), all within 28 calendar days from randomization)
研究者
Jun Liu
Attending Physician
Affiliated Hospital of Jiangnan University