The Effect of Prone Position Drainage on the Efficacy of Severe Pneumonia，a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The changes in C-reactive protein
研究概览
简要总结
Enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, Select all eligible patients with severe pneumonia(SP) who were admitted to the hospital during the study date.The diagnostic criteria we will use for SP are based on the Infectious Diseases Society of America/American Thoracic Society guidelines.Primary outcome measures：a.CURB-65 Score for Pneumonia Severity;b.The changes in inflammation and coagulation indicators: C-reactive protein, procalcitonin, and d-dimer;c.Chest x-ray changes;d.Mortality rate after 28 days;e.The time of mechanical ventilation, total duration of ICU stay, hospitalization, and antibiotic use;f.The time of bacterial cultures becoming negative;g.Daily sputum drainage.The aim of this study is to evaluate the anti-infective effectiveness and safety of prone position drainage compared with supine position on SP treatment.
详细描述
Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Randomized, controlled trials have confirmed that oxygenation is significantly better when patients are in the prone position than when they are in the supine position.But whether prone drainage is beneficial for rapid infection control on SP treatment has not been researched.The aim of this study is to evaluate the anti-infective effectiveness and safety of prone position drainage compared with supine position on SP treatment.
Using a central randomization system, participants will be randomized (1:1) into groups receiving either placed in prone position or in supine position (within 24 h of diagnosis of SP) for 5-7 days with a 28-day follow-up. Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours.
The patients enrolled in this study should meet the diagnostic and inclusion criteria and provide written informed consent.
Diagnostic criteria The diagnostic criteria we will use for SP are based on the Infectious Diseases Society of America/American Thoracic Society guidelines.
The inclusion criteria are as follows:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤75 years, male or female
- •Weight ≥40 kg and ≤100 kg
- •Meet the diagnostic criteria for SP
- •Need invasive mechanical ventilation
- •Provide signed informed consent
排除标准
- •Contraindication for prone positioning：a. Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg;b. Massive hemoptysis requiring an immediate surgical or interventional radiology procedure; c. Tracheal surgery or sternotomy during the previous 15 days;d. Serious facial trauma or facial surgery during the previous 15 days;e. Deep venous thrombosis treated for less than 2 days; f. Cardiac pacemaker inserted in the last 2 days;g. Unstable spine, femur, or pelvic fractures;h. Mean arterial pressure lower than 65 mm Hg;i. Pregnant women; j. Single anterior chest tube with air leaks.
- •Respiratory reason：a. Inhaled nitric oxide (NOi) or almitrine bismesylate use before inclusion;b. Use of extracorporeal membrane oxygenation (ECMO) before inclusion.
- •Clinical context：a. Lung transplantation;b. Burns on more than 20 % of the body surface;c. Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation(NIV);d. Underlying disease with a life expectancy of less than one year;e. NIV delivered for more than 24 hours before inclusion.
- •Other non-inclusion criteria ：a. End-of-life decision before inclusion;b. Inclusion in another research protocol in the previous 30 days with mortality as the main end-point;c. Prone positioning before inclusion;d. Subject deprived of freedom, minor, subject under a legal protective measure;e. Opposition from next of kin.
研究组 & 干预措施
The prone group
Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours.
干预措施: Placed in prone position for at least 16 consecutive hours a day. (Behavioral)
The supine group
Patients assigned to the supine group had to be turned within the first hour following randomization. They were placed in supine position for at least 16 consecutive hours.
结局指标
主要结局
The changes in C-reactive protein
时间窗: On the tenth day after hospitalization
Use C-reactive protein to assess the patient's lung infection status
The time of antibiotic use
时间窗: 28 day
Calculate the time of antibiotic use
The changes in procalcitonin
时间窗: On the tenth day after hospitalization
Use procalcitonin to assess the patient's lung infection status
The changes in d-dimer
时间窗: On the tenth day after hospitalization
Use d-dimer to assess the patient's lung infection status
Chest x-ray changes
时间窗: On the tenth day after hospitalization
Use Chest x-ray to assess the patient's lung infection status
Mortality rate after 28 days
时间窗: 28 days after admission
Calculate patient 28-day mortality
The time of total duration of ICU stay
时间窗: 28 day
Calculate The time of total duration of ICU stay
The time of mechanical ventilation
时间窗: 28 day
Calculate The time of mechanical ventilation
mortality
时间窗: 28 day
Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days
The time of bacterial cultures becoming negative
时间窗: 28 day
Calculate the time of bacterial cultures becoming negative
Daily sputum drainage
时间窗: On the tenth day after hospitalization
Calculate daily sputum drainage
次要结局
未报告次要终点