COMPARATIVE EFFICACY OF HIGH FLOW NASAL CANNULA VERSUS NON-INVASIVE VENTILATION IN PATIENTS WITH ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To compare the rate of change in values of arterial partial pressure of carbon dioxide (Pco2) and pH from baseline arterial blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease treated with high flow nasal cannula versus non-invasive ventilation at 2 hours from enrollment in study
研究概览
简要总结
It is a prospective open label randomized controlled trial of parallel group to compare the efficacy of high flow nasal cannula oxygen therapy versus non-invasive ventilation in patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease. After providing standard medical treatment (in the form of bronchodilators , oxygen , steroids and antibiotics) to the patients of AECOPD , those who do not improve with it will be randomized using computer generated randomisation sequence and allocation concealment will be through SNOSE technique. All patients who will be recruited in the study will be explained about the study , given a patient information sheet and they will sign a consent form provided both in hindi and english.
Our primary objective of doing the study is to compare rate of pH and PaCO2 change from baseline to 2 hours between both HFNC and NIV group .
Secondary objectives include comparing rate of pH and PaCO2 change from baseline to 6 hours between both HFNC and NIV group , comparing rate of treatment failure in both groups , rate of treatment switch in both groups , need for mechanical ventilation in both groups, length of emergency department and hospital stay in both groups and mortality within hospital and from 30 days of enrollment between both groups.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS WITH AGE MORE THAN OR EQUAL TO 18 YEARS WITH AECOPD.
排除标准
- •Patients who have already received HFNC or NIV prior to enrollment in study Patients who are on long term domiciliary NIV support Patients who are in need of vasopressor support Patients with acute coronary syndrome or life-threatening arrhythmias Unconscious or uncooperative patients Patients who are in cardiorespiratory arrest and those who require mechanical ventilation Patients who suffered recent trauma to neck or face Pregnant females Patients who are on treatment with palliative intent Patients having active hemoptysis or active upper gastrointestinal bleeding Patients having pneumothorax, neuromuscular weakness.
结局指标
主要结局
To compare the rate of change in values of arterial partial pressure of carbon dioxide (Pco2) and pH from baseline arterial blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease treated with high flow nasal cannula versus non-invasive ventilation at 2 hours from enrollment in study
时间窗: At 2 hours
次要结局
- To compare the rate of change in values of arterial partial pressure of carbon dioxide (Pco2) & pH from baseline arterial blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease treated with high flow nasal cannula versus non-invasive ventilation at 6 hours from start of treatment
研究者
DR AASTHA TIWARI
AIIMS NEW DELHI