Human Research Program Flight Thigh Cuff
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venoconstrictive Thigh Cuff (VTC).
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
Overview
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.
Interventions
- Device Venoconstrictive Thigh Cuff (VTC)
The VTC is an adjustable fabric cuff that is worn on the upper thighs to retain some fluid in the legs. It consists of wide straps and a buckle which allow it to be tightened, then velcro to secure the strap in the tightened position. There is also lacing that can be tightened for micro adjustments. Imbedded within the fabric strap is a bladder that is not used for increasing tightness but allows the pressure of the cuff to be measured and tracked.
Primary outcome measures
- Internal Jugular Vein (IJV) area [Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return]
- IJV pressure [Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return]
- Intraocular Pressure (IOP) [Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return]
- stroke volume [Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return]
Eligibility criteria
Inclusion criteria
- Astronauts participating in missions that are ≥2 months
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Johnson Space Center, National Aeronautics and Space Administration — Houston
Identifiers
NCT: NCT06476106 · STUDY00000453