High flow nasal cannula therapy (HFNC) vs Non-Invasive Ventilation (NIV) in acute hypercapnic chronic obstructive pulmonary disease (COPD) exacerbation- a non inferiority randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate whether HFNC therapy is non-inferior to NIV in reducing arterial pCO2 and pH after 12 and 24 hours of treatment in patients with acute exacerbation of COPD.
研究概览
简要总结
This study is a randomized controlled non-inferiority trial comparing High Flow Nasal Cannula (HFNC) therapy with Non-Invasive Ventilation (NIV) in patients experiencing acute hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD). Given the high burden of COPD in India and limitations associated with NIV such as discomfort, poor tolerance, and failure in up to 30% of cases, the study aims to evaluate whether HFNC, which offers better patient comfort and similar efficacy in managing respiratory acidosis, can be a non-inferior alternative. The primary objective is to assess changes in arterial pCO2 and pH after 12 and 24 hours of treatment, while secondary objectives include changes in respiratory rate, dyspnea score, and treatment modifications. The findings are expected to support HFNC as an effective and more tolerable therapeutic option for managing acute hypercapnic COPD exacerbations in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults diagnosed with COPD exacerbation according to GOLD criteria.
- •Arterial pH between 7.25 to 7.35 at time of presentation (mild to moderate exacerbation) Arterial PaCO2 more than 45mmHg at time of presentation.
排除标准
- •Patient who are on long term domiciliary NIV therapy.
- •Clinical cardiovascular instability.
- •Acute failure of more than equal to two organs.
- •Need for immediate intubation or cardiorespiratory arrest.
- •Facial / neck trauma or deformity Consent withdrawal.
- •Treatment refusal.
结局指标
主要结局
To evaluate whether HFNC therapy is non-inferior to NIV in reducing arterial pCO2 and pH after 12 and 24 hours of treatment in patients with acute exacerbation of COPD.
时间窗: At the end of 12 hours and 24 hours from baseline
次要结局
- To evaluate the change in respiratory rate, dyspnea score using Modified Borg scale, and treatment change rates at 12 and 24 hours of treatment.(At the end of 12 hours and 24 hours from baseline.)
研究者
Dr Aditya Bhargav K
SDM college of medical sciences and hospital