Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Internal Jugular Vein (IJV) area
研究概览
简要总结
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Astronauts participating in missions that are ≥2 months
排除标准
- •Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
- •Use of ethinyl estradiol Combined Oral Contraceptive (COC) pills precludes participation in this study
- •Having increased risk of venothromboembolism (VTE) based on preflight thrombosis/clotting related biomarkers precludes participation in this study
结局指标
主要结局
Internal Jugular Vein (IJV) area
时间窗: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using Ultrasound.
Intraocular Pressure (IOP)
时间窗: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using the Pneumatonometer.
stroke volume
时间窗: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured from data collected during Ultrasound.
IJV pressure
时间窗: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using the VeinPres device during Ultrasound.
次要结局
未报告次要终点