Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- urinary output (ml)
研究概览
简要总结
Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Acute hypercapnic COPD exacerbation
- •Respiratory acidosis
- •Intensive care unit admission
- •Non-Invasive mechanical ventilation for less than 24 hours
- •Patients or proxy consent
- •Patients affiliated with the General Social Security Health System
排除标准
- •Pregnancy
- •Sickle cells disease
- •Acute coronary syndrome
- •Restrictive respiratory disease
- •Stage 4 or 5 chronic kidney disease
- •COPD exacerbation following a first episode of conventional mechanical ventilation
- •Contraindications to non-invasive ventilation
研究组 & 干预措施
control
干预措施: Non-invasive mechanical ventilation - Controlled hypoxemia (Device)
intervention
干预措施: Non-invasive mechanical ventilation - Normoxia (Device)
结局指标
主要结局
urinary output (ml)
时间窗: 24 hours
First 24 hours of non-invasive mechanical ventilation
次要结局
- Pulmonary arterial pressure(24 hours, 48 hours, 72hours)
- Serum creatinine(24 hours, 48 hours, 72hours)
- Renal resistive index(24 hours, 48 hours, 72hours)
- Changes in CO2 levels(24 hours, 48 hours, 72hours)
- Fluid balance(24 hours, 48 hours, 72hours)
- SOFA (Sequential Organ Failure Assessment) score(24 hours, 48 hours, 72hours)
- respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)(24 hours, 48 hours, 72 hours)
- Semiquantitative assessment of comfort (visual likert scale)(24 hours, 48 hours, 72hours)
- Mortality(up to day 28)
- Semiquantitative assessment of dyspnea (visual likert scale)(24 hours, 48 hours, 72hours)
- Number of patients requiring mechanical ventilation(up to day 28)
- days alive without mechanical ventilation(up to day 28)