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临床试验/NCT02860975
NCT02860975终止不适用

Physiological and Biochemical Response to Prolonged Exposure to Hypoxic Breathing in Healthy Volunteers

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenzo Berra, MD

Assistant Professor of Anesthesia

Massachusetts General Hospital

研究点 (2)

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