Lower Body Negative Pressure to Validate Physiological Monitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Arterial Oxygen Saturation During Lower Body Negative Pressure
研究概览
简要总结
The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-obese (BMI<30)
- •Non-smokers
- •Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
- •Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test (within 48 hours of the study day)
排除标准
- •Individuals taking GLP-1 medications or compounds known to affect responses of the autonomic nervous system to orthostatic stress (e.g., β-blockers)
- •Pregnant women
研究组 & 干预措施
Healthy Volunteers Undergoing Lower Body Negative Pressure
Healthy adult participants will complete one study visit involving graded lower body negative pressure while standard physiological reference measurements and noninvasive investigational physiological monitor data are collected.
干预措施: Lower Body Negative Pressure with Noninvasive Physiological Monitoring (Diagnostic Test)
结局指标
主要结局
Arterial Oxygen Saturation During Lower Body Negative Pressure
时间窗: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Arterial oxygen saturation will be measured during lower body negative pressure using noninvasive physiological monitors
ECG Waveform During Lower Body Negative Pressure
时间窗: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
ECG waveform will be measured during lower body negative pressure using noninvasive physiological monitor
Respiratory Rate During Lower Body Negative Pressure
时间窗: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Respiratory rate will be measured during lower body negative pressure using noninvasive physiological monitors
Plethysmography Signals During Lower Body Negative Pressure via physiological monitors
时间窗: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Plethysmography signals will be measured during lower body negative pressure from the pulse oximetry. Reported as a non-invasive research metric of central blood volume.
Heart rate During Lower Body Negative Pressure
时间窗: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Heart rate will be measured during lower body negative pressure using noninvasive physiological monitors
次要结局
未报告次要终点
研究者
Michael J. Joyner, M.D.
Principal Investigator
Mayo Clinic