High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Effectiveness as determined by weaning success rates
研究概览
简要总结
The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal intubation.
详细描述
For over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of HFCWO in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. However, these outcomes of HFCWO on PMV patients remain unknown.
This parallel-design, randomized controlled trial aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in PMV patients with intra-tracheal intubation. Moreover, the safety and tolerance/comfort of HFCWO in PMV patients after removal of endotracheal tubes were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
- •age ≥20 year-old
- •having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
- •alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
- •scheduled extubation within 24 hours after enrollment
- •without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)
排除标准
- •those who had undergone tracheostomy
结局指标
主要结局
Effectiveness as determined by weaning success rates
时间窗: up to 5 days after extubation
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
Effectiveness as determined by daily clearance volume of sputum
时间窗: up to 5 days after extubation
The daily clearance volume of sputum was determined by the numbers of sputum suction per day
Effectiveness as determined by serial changes in sputum coloration
时间窗: up to 5 days after extubation
The sputum coloration was determined by the Color Card for Body Fluid (CCBF). The CCBF was designed to have 27 different categories to describe the color of the body fluid. Each category was assigned an Arabic numeral and the larger the Arabic numeral, the darker the color of the body fluid. The scoring of sputum coloration was based on the perception of the interviewer who was blinded to the intervention.
Effectiveness as determined by chest X-ray improvement rates
时间窗: up to 5 days after extubation
Baseline and follow-up CXRs were taken on the day of extubation and on the 5th day after extubation, respectively, in both groups. Serial changes in CXR were graded as "improved", "no change", or "progressed", as determined by the severity of lung infiltrates, which were defined by two independent chest specialists blinded to the study groupings. If no consistency between two specialists, the grading would be judged by the third chest specialist.
次要结局
- safety as determined by the changes of blood pressures before and after HFCWO(up to 5 days after extubation)
- safety as determined by the changes of heart rates before and after HFCWO(up to 5 days after extubation)
- safety as determined by the changes of respiratory rates (RR) before and after HFCWO(up to 5 days after extubation)
- safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO(up to 5 days after extubation)
- tolerance/comfort as determined by Modified Borg Scale (MBS)(up to 5 days after extubation)
- tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)(up to 5 days after extubation)
研究者
TCVGH
Taichung Veterans General Hospital
Taichung Veterans General Hospital