NCT07395297招募中不适用
The Effectiveness Study of OLE Airway Clearance Therapy in ICU Patients With Pulmonary Infections in EIT Evaluation.
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Cough Peak Flow
研究概览
简要总结
This study aims to explore the application of Electrical Impedance Tomography (EIT) in evaluating the effectiveness of OLE (Oscillatory Lung Expansion) airway clearance therapy for ICU patients with pulmonary infections. The goal is to understand the treatment response differences in patients with various causes of atelectasis (lung collapse). The study will include adult patients diagnosed with pulmonary infections and admitted to the ICU. The primary endpoint of the study is the peak cough flow (CPF), which measures the patient's ability to clear secretions from the lungs through coughing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clearly diagnosed with pulmonary infection in the ICU, confirmed by microbiological tests (sputum culture, blood culture, etc.) or imaging tests (chest CT, chest X-ray);
- •Age ≥ 18 years;
- •Respiratory support is oxygen therapy (nasal cannula or face mask oxygen therapy);
- •Sputum volume > 30 ml/day;
- •The patient or their legal representative signs the informed consent form.
排除标准
- •Pregnant or breastfeeding women;
- •Presence of respiratory or circulatory failure (requiring mechanical ventilation or vasopressor support to maintain circulation);
- •Untreated tension pneumothorax;
- •Body Mass Index (BMI) exceeding 50 kg/m²;
- •Rib deformities or severe thoracic deformities;
- •Contraindications for the use of EIT (such as implanted automatic cardiac defibrillators, acute chest trauma, subcutaneous implanted pumps, etc.);
- •Early withdrawal from the study or incomplete clinical data.
研究组 & 干预措施
OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections
Experimental
干预措施: Oscillatory Lung Expansion (OLE) Therapy (Device)
结局指标
主要结局
Cough Peak Flow
时间窗: Day 1
次要结局
- Lung Ultrasound Score(Day 1)
- Sputum Viscosity(Day 1)
- Cough Dysfunction Score(Day 1)
- Heart rate(Day 1)
- diastolic pressure(Day 1)
- systolic pressure(Day 1)
- Tidal Impedance Variation Before Cough (TIV)(Day 1)
- End-Expiratory Lung Impedance (EELI)(Day 1)
- Center of Ventilation (COV)(Day 1)
- Ventilation Heterogeneity Index (GI)(Day 1)
研究者
wang kaifei
Professer
Chinese PLA General Hospital
研究点 (1)
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