Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Increases Oxygen saturation (SpO2) with RMO
研究概览
简要总结
The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18-40 years,
- •body mass index between 19 and 30 kg/m^2,
- •resident at a similar altitude for a minimum of 1-year,
- •no travel to/from areas varying by ~2000 feet of elevation within 4-weeks of initiation of study participation.
排除标准
- •identification of overt chronic disease (including cardio-pulmonary disorders),
- •prior diagnosis of asthma, cystic fibrosis, Chronic obstructive pulmonary disease, or ventilator therapy
- •pregnancy,
- •habitual use of tobacco/nicotine products,
- •known allergy to sodium phosphate (or other common laxatives),
- •habitual use of recreational drugs that require inhalation,
- •history of seizures, kidney problems, stomach or bowel problems, ulcerative colitis, problems with swallowing or gastric reflux, gout, and and/or low blood sodium.
- •irritable bowel
- •ACUTE respiratory illness such as bronchitis, pneumonia, Upper Respiratory Infection OR ACUTE GI issues such as gastroenteritis.
- •Anemia (as measurement of hemoglobin and/or hematocrit) .
- •sickle cell disease.
- •history of altitude sickness
研究组 & 干预措施
Low Oxygen Visits with Respirogen Micro-Oxygen
During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.
干预措施: Respirogen Micro-Oxygen (Drug)
结局指标
主要结局
Increases Oxygen saturation (SpO2) with RMO
时间窗: Randomized crossover, visits separated by a minimum 7 days and maxim 14 days
Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures.
次要结局
未报告次要终点
研究者
Christopher Bell
Associate Professor
Colorado State University