Physiological and Biochemical Response to Prolonged Exposure to Hypoxic Breathing in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Peripheral oxygen saturation
研究概览
简要总结
The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.
详细描述
The primary endpoint of this research study is to prove safety in healthy subjects breathing humidified hypoxic inspiratory gas mixture for 5 days.
The secondary endpoint of our study is to describe the physiological and biochemical changes during the 5-day hypoxic period and the 2 days after return to normoxia.
The specific aims are as follows:
AIM 1: To provide a safe, controlled setting for prolonged exposure of monitored healthy adults to a normobaric, low-oxygen environment for five days.
AIM 2: To carry out a seven-days long pilot safety-study in twelve healthy young subjects by inducing hypoxia with a humidified normobaric gas mixture containing oxygen (O2) content as low as 11% to reach a peripheral oxygen saturation (SpO2) between 80%-85%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have a photo identification (ID)
- •Male or female individuals age between 18 and 40 years old
- •BMI between 19 and 24.9 kg/m2
- •Having capacity to consent to the study
排除标准
- •Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous
- •Prior high altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- •Born at altitudes greater than 2,100 m (~7,000 ft)
- •Systemic disease with or without any functional limitation; including
- •controlled hypertension
- •controlled diabetes without systemic effects
- •Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
- •Women who are not willing to receive urine pregnancy tests
- •Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year.
- •Excess alcohol use: more than ½ L/day of wine consumption or equivalent
- •Any current medication use except oral contraceptives.
- •Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for more than four days within the last 2 months
- •Tobacco chewers
- •Abnormal hemoglobin or hematocrit levels or presence of hemoglobin S
- •Evidence of apnea or other sleeping disorders
- •Evidence of asthma
- •Lower respiratory infection within the last 30 days
- •If applicable, unwilling to refrain from using energy drinks or other caffeinated beverages for 7 days prior to and during the study
- •If applicable, unwilling to refrain from use of all over-the-counter oral medications, herbal remedies, and nutritional supplements for 7 days prior to and during the study
- •Not willing to have blood drawn from an arm vein each test day of the study
- •Claustrophobia (inability to wear a facemask) or other active psychiatric conditions or not willingness to cooperate with the investigators and the other medical team
- •Currently enrolled in another research study
- •Facial abnormalities that would preclude proper use of a face mask
- •Pregnancy Prevention/Testing: Women using oral, subdermal or injectable contraceptives, and those using other means of birth control may participate. A urine pregnancy test will be conducted as part of the screening process for study participation no more than 7 days before starting the study. The test result will be read by a female staff member who will keep the result confidential. If a woman declines to have a pregnancy test, she will not be able to participate.
研究组 & 干预措施
Inhaled Nitrogen
A humidified mixture of gas will be delivered by mask, nasal cannulae, and small room-sized tent. Inspiratory oxygen fraction (FiO2) will be gradually decreased to 11% over a period or five days to obtain a peripheral capillary O2 saturation (SpO2) between 80%-85% (corresponding to 40-55 mmHg of arterial partial oxygen pressure (PaO2)). Healthy volunteers will be monitored and blood and urine will be obtained at 24h and 48 hours after returning to normoxia.
干预措施: Inhaled Nitrogen (Other)
结局指标
主要结局
Peripheral oxygen saturation
时间窗: 7 days
Peripheral oxygen saturation of the healthy volunteers receiving different levels of FiO2 will be continuously monitored for the 5 days of hypoxia titration and the 2 days after return to normoxia.
Peripheral Oxygen Saturation
时间窗: 7 days
The average of the lowest SpO2 recorded during daytime hours over the 7 days timeframe of the study.
次要结局
- Anaerobiotic glycolytic pathway(7 days)
- Pulmonary pressure(7 days)
- Mitochondrial oxidative stress(7 days)
- Acid-base status(7 days)
- Systemic blood pressure(7 days)
- Heart rate(7 days)
- Energy metabolism(7 days)
- Respiratory rate(7 days)
- Erythropoiesis(7 days)
- Erythropoiesis(5 days)
- Pulmonary Pressure(5 days)
研究者
Lorenzo Berra, MD
Assistant Professor of Anesthesia
Massachusetts General Hospital