Flexible-bronchoscopy Trial for Moderate and Severe Thoracic Trauma Patients Without Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Rate of pneumonia
研究概览
简要总结
The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes.
详细描述
The aim of the present randomized control trial is to assess the value of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. To decrease group differences in baseline characteristics and blood gas conditions, patients will be randomly assigned to receive either bronchoscopy-assisted or negative pressure aspiration for sputum suction, while the remaining treatment course will be the same. The study will measure major clinical indicators such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate to provide strong evidence for the efficacy of each suction method.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 20 years of age or older.
- •Participants of all genders are eligible.
- •Participants who are not in good health are not eligible.
- •Participants with an Injury Severity Score greater than 9 and who have chest trauma are eligible.
排除标准
- •Patients with traumatic brain injury.
- •Patients with active pulmonary tuberculosis or other respiratory diseases with suspected contagion.
- •Patients with poor blood clotting function or a tendency to bleed.
- •Patients with aortic aneurysm. Patients with unstable vital signs or those who cannot maintain oxygen saturation above 90% while performing the test with Fraction of Inspired Oxygen (FiO2) greater than 80% or on 100% oxygen.
- •Immunocompromised patients.
- •Patients with acute massive hemoptysis.
- •Patients with pre-existing neuromuscular diseases or those at high risk for arrhythmias, myocardial ischemia, or pulmonary embolism.
- •Patients who are unable to clearly express their willingness to sign the informed consent form.
- •Patients who have frequent intermittent sputum suction or are unable to fast for 4 hours due to their medical condition.
研究组 & 干预措施
bronchoscopic suction
Bronchoscopic suction is a medical procedure used to remove excess mucus, secretions, and foreign objects from the airways through a bronchoscope. The patient would receive bronchoscopic sputum suction every 24-48 hrs after randomization until leaving ICU.. The patient could still receive blind negative pressure aspiration suction as the usual medical routine(every 2-4 hrs sputum suction if needed).
干预措施: bronchoscopic sputum suction (Procedure)
blind negative pressure aspiration suction
Negative pressure aspiration suction is a medical procedure that uses suction to remove fluids, mucus, or other materials from the body by creating a negative pressure or vacuum. The procedure involves inserting a catheter into the airway and applying negative pressure to the catheter to suction out the secretions or fluids. The patient would receive blind negative pressure aspiration suction as the usual medical routine(every 2-4 hrs sputum suction if needed).
干预措施: negative pressure aspiration suction (Procedure)
结局指标
主要结局
Rate of pneumonia
时间窗: 30 days after randomization
diagnosis of pneumonia was determined according to radiologic evidence of new or progressive infiltrate of more than 48 hours and laboratory detection of a causative agent. The management and diagnosis of all patients was performed by a trauma specialist.
次要结局
- Intensive Care Unit admission interval(30 days)
- admission interval(up to 24 weeks (from randomization to discharge))
- tracheostomy rate(up to 24 weeks (from randomization to discharge))
- intubation rate(90 days)