Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Rate of ventilator associated pneumonia
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays.
The mechanical insufflation/exsufflation (M-I/E) cough assist device improves outcomes in patients with neuromuscular disorders but its effects on brain-injured patients are largely unknown.
This study is conducted at a tertiary neurosurgical medical center and consists of two substudies. The prospective physiological study assessed the impact of M-I/E on hemodynamics and ICP in mechanically ventilated neurosurgical patients. The combined retrospective-prospective clinical study was performed to investigate the efficacy of M-I/E on occurence of VAP and other clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Post-neurosurgical adult patients
- •>18years old
- •Body mass index (BMI) <35kg/m2)
- •Receiving mechanical ventilation
- •With arterial blood catheter for continuous pressure measurement and/or ventricular catheter drainage for ICP measurement (only for study one)
排除标准
- •ICP > 22cmH2O or evidence of increased ICP
- •Hemodynamically unstable (SBP< 90 or > 160 mmHg; DBP < 50 or > 110 mmHg, using cardiovascular medicine to maintain pressure, or known cardiac failure)
- •Patients with lung trauma, emphysema, bronchopleural fistula or risk of pneumothorax
- •History of mechanical ventilation and pneumonia within 6 months before ICU admission
结局指标
主要结局
Rate of ventilator associated pneumonia
时间窗: Within 7 days after the onset of mechanical of ventilation
In study two, ventilator associated pneumonia is defined as pneumonia occurring in patients who have been mechanically ventilated for at least 48 hours. Pneumonia was diagnosed by clinical features (e.g., cough, fever, pleuritic chest pain) and by lung imaging. To derived the diagnosis of pneumonia, patient electronical record, lab results, and images were extracted from the electronical system.
Heart rate
时间窗: During the process of physiological study, up to 2 hours
In study one, heart rate will be recorded during the incremental pressure changes in the study one
Mean blood pressure
时间窗: during the process of physiological study, up to 2 hours
In study one, mean blood pressure will be recorded during the incremental pressure changes in the study one
次要结局
- Intracranial pressure(During the process of physiological study, up to 2 hours)
- Length of stay in ICU(Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came first,through study completion, an average of 1 year)
- Length of hospital stay(Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year)
- Days of receiving mechanical ventilation(Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year)
研究者
Zhonghua Shi, MD, PhD
vice president of dept. ICU
Beijing Sanbo Brain Hospital