TCTR20201005006尚未招募3 期
Comparison of the efficacy of budesonide pressurized metered-dose inhaler and systemic steroids in acute COPD exacerbation: a non-inferiority randomized controlled trial study
Routine to research unit, Faculty of medicine, Siriraj hospital0 个研究点目标入组 120 人开始时间: 2020年10月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •1. patients who have already been diagnosed as COPD
- •2. patients who come to ED , Siriraj hospital with acute exacerbation of COPD within 1 hour after initial treatment
排除标准
- •1. patients with signs of respiratory failure according to 1 or more of these criteria
- •1.1 attending physician's decision to intubate, or support ventilation with NIV/BIPAP
- •1.2 RR > 30/min, accessory muscles uses, cyanosis, patients who need FiO2 > 0.4 to keep SpO2 > 92%
- •1.3 ABG pH < 7.25 and/or PaCO2 > 50 mmHg
- •1.4 alteration fo consciousness
- •1.5 new onset limb edema or cardiac arrhythmia or hypotension requiring vasopressors
- •2. Presence of pneumothorax
- •3. Cardiac arrest or history of cardiac arrest
- •4. Patient with tracheostomy
- •5. Patients who need home oxygen therapy or CPAP at home
- •6. Patients who cannot follow study methods effectively or safely for example one who can't tolerate MDI with spacer, can't do the spirometry test
- •7.Patients who have other life-threatening or other emergency conditions requiring immdediate stabilization
- •8. Patients or attending physician decline participation
- •9. Patients who has already been treated with IV or Oral steroids within 1 month prior to inclusion
- •10. Patients whom the attending physician deem not requiring steroid therapy
- •11. Patients who has history of COPDAE with respiratory failure or ICU admission
- •12. Patients who are allergic to study drugs
- •13. Patients who have concomittant heart or lung diseases eg. Chronic heart failure, Chronic coronary artery disease, pneumonia, bronchiectasis
研究者
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