JPRN-jRCTs052190042已完成1 期
Randomized cross-over trial of demand oxygen delivery system in HOT patients with nocturnal hypoxemia
agano Tatsuya0 个研究点目标入组 19 人开始时间: 2019年8月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
The primary endpoint was the mean value of SpO2, but the difference in SpO2 between continuous flow and auto demand was 0.835% (95% confidence interval [0.1334, 1.5366]) in the study based on the difference in timing. The upper limit of the difference did not exceed 2.8, which was set as the non-inferiority margin. Therefore, it was shown that autodemand did not reduce SpO2 by at least 2.8% on average compared to the continuous dose. No equipment failure or exacerbation of disease was observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Home oxygen therapy
- •2. Chronic obstructive pulmonary disease or interstitial pneumonia
- •3. Ambulatory patients with portable device
- •4. Written informed consent
- •5. More than 20 years old
排除标准
- •1. Noninvasive positive pressure ventilation therapy
- •2. Continuous Positive Airway Pressure therapy
- •3. Symptomatic congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to registration, clinically severe arrhythmia (CLBBB, 2nd and 3rd degree AV block, Vf)
- •4. Hemoglobin < 9 g/dL
- •5. History of acute exacerbation of chronic obstructive pulmonary disease or interstitial pneumonia within 3 months
- •6. Pregnant women or women who may be pregnant or breastfeeding
- •7. A judgment by the attending physician that patient participation would be inappropriate
研究者
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