KCT0006608招募中未知
Multicenter, Prospective, Comparative, Randomized, Non-inferiority, Investigator-Initiated Study to evaluate the clinical effectiveness and safety of Automatic, Closed-Suction System ‘A-1000’ in Mechanically Ventilated patients with Pneumonia (ESuction-MVP)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Selection criteria
- •1. Adults over 19 years of age
- •2. Critical patients who are diagnosed with pneumonia and need mechanical ventilation
- •3. A person who voluntarily decided to participate in this clinical trial and agreed to the subject's explanation and consent in writing
- •4. A person who is willing to comply with the clinical trial plan
排除标准
- •1. A person who does not receive a bronchoscopy
- •2. If you are not expected to maintain mechanical ventilation for at least 3 days because you are in critical condition with an APACHE II score of 30 or higher, which is expected to be evaluated after 24 hours of initial admission for simple monitoring;
- •3. If the ventilator setting is FiO2>80% (intake oxygen concentration) or Plat(pressure when resting before exhalation)>30cmH2O is required to maintain high flat airway pressure
- •4. In the case of progressive blood cancer, failure to transplant bone marrow, granulocytosis, and severe immunodeficiency conditions such as ANC<400/mm3
- •5. If you have blood transfusions
- •6. Pregnant women or persons planning to conceive during the clinical trial period;
- •7. A person who has received CPR within five days of the screening date
- •8. Other cases where the medical staff finds it difficult to apply the medical device in consideration of the patient's condition;
- •9. A person who is currently participating in another clinical trial or has participated in another clinical trial within 90 days as of the screening date
- •10. Other cases where the tester determines that it is difficult to apply the medical device considering the patient's condition or that participation in the clinical trial is inappropriate because it may affect the results of the clinical trial.
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