COMPARATIVE EVALUATION OF EFFECTS OF HIGH FLOW NASAL OXYGEN THERAPY AND NON- INVASIVE VENTILATION IN PATIENTS WITH ACUTE EXACERBATION OF COPD IN COMBINATION WITH TYPE TWO RESPIRATORY FAILURE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is a prospective randomized interventional trial aimed at comparing the effectiveness of High-Flow Nasal Oxygen (HFNO) and Non-Invasive Ventilation (NIV) in patients with acute exacerbation of COPD (AECOPD) with Type II respiratory failure. COPD is a major global health problem, and while NIV is the current standard treatment, it has limitations such as poor tolerance and significant failure rates. HFNO has emerged as a promising alternative due to better patient comfort, improved oxygen delivery, and reduction in work of breathing.
The primary objective is to compare the reduction in PaCO2 levels between HFNO and NIV. Secondary objectives include comparison of PaO2 improvement, patient comfort, and treatment failure rates.
A total of 100 patients (18–70 years) meeting inclusion criteria will be enrolled and randomly allocated into two groups: HFNO (50 patients) and NIV (50 patients). Clinical parameters, arterial blood gases, and indices like the ROX index will be monitored at predefined intervals over 24 hours or until treatment failure.
Data will be analyzed using appropriate statistical methods (SPSS), with significance set at p less than 0.05.
The study aims to determine whether HFNO can be a better or comparable alternative to NIV in managing hypercapnic respiratory failure in COPD exacerbations, potentially improving patient outcomes and comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed mild to moderate AECOPD with Type 2 respiratory failure Patient or legally authorized representative providing informed consent.
排除标准
- •ANY NEED FOR URGENT INTUBATION PH LESS THAN 7.2 Severe hypoxia pO2 LESS THAN 50 Respiratory rate LESS THAN 8 or MORE THAN 40 Inability to protect airways Respiratory or cardiac arrest Requirement for urgent intubation Factors such as suspected drug overdose, end-stage cancer, cerebrovascular accident, recent myocardial infarction, hemodynamic instability, HISTORY OF Pulmonary Kochs Ischemic Heart Disease Arrythmias Pericarditis Pulmonary edema Pleural effusion.
研究者
DR SANJAY KUMAR GUPTA
Hindu Rao Hospital Delhi