Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500338
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels
Sponsor:
National Aeronautics and Space Administration NASA
Organization:
National Aeronautics and Space Administration NASA
Study Overview
Official Title:
Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AG2
Brief Summary:
Parabolic flight provides a unique opportunity to evaluate the acute changes associated with varying levels of gravity and to describe how key venous parameters change at levels less than normal Earth gravity Characterizing these changes in response to varying G-levels is an important step in determining what G-level may be required to reverse weightlessness-induced fluid shifts and thus serve as a viable countermeasure during long-duration spaceflight Further these results will inform National Aeronautics and Space Administration NASA whether there might be a lower risk of Spaceflight Associated Neuro-ocular Syndrome SANS and Venous Thromboembolism VTE during extended stays on the Moon and Mars
Detailed Description:
Subjects first will be studied for baseline data collection BDC on Earth in a 1 gravity-level G environment while seated and supine During baseline data collection the operator will identify the proper location of the internal jugular vein measurement below the confluence of the internal jugular vein and superior thyroid vein using ultrasound and mark this location with a marker so subsequent scans can be taken in the same location Thereafter six electrocardiogram electrodes will be adhered to the skin of the chest and connected to the ultrasound machine and to a data recording system A small blood pressure cuff will be placed around one finger blood pressure also will be recorded continuously The blood pressure cuff will be inflated preflight during baseline data collection and inflight during the parabolas Baseline ultrasound images of the internal jugular vein will be acquired in the seated and supine positions on the ground Measurements will include 2D ultrasound of the right and left internal jugular veins for measurement of cross-sectional area and pressure and Doppler ultrasound of the right and left internal jugular veins for flow characterization
Anti-motion sickness medication is distributed to flying participants at their discretion Participants board the Airbus A310 aircraft fasten seatbelts for takeoff After takeoff the pilots fly the aircraft to a specific air zone where the parabolas will take place With other members of the participants group participants will then move to the area of the cabin in which data will be collected Participants will receive instructions from Novespace to maintain safety during the parabolic flight
The aircraft will fly in parabolas that initially produce increased gravity 18-G hypergravity followed by 20-50 second periods of partial gravity or weightlessness After that there will be another pull-up hypergravity to complete the parabola The plane then will fly in normal horizontal flight for a few minutes before repeating the parabolic flight path again The pilots will perform this sequence of maneuvers many times The number of times the level of reduced gravity and the order of reduced gravity exposures will depend upon the flight plan for that day Subjects will be informed of the flight plan in the pre-mission briefing conducted by Novespace Flights which produce partial gravity 025- 050- and 075-gravity generally will consist of 31 parabolas at least 10 parabolas at each gravity level and flights that produce weightlessness generally will consist of 16 parabolas The total flight time from take-off to landing is approximately 2-3 hours
During the flight subjects will be seated in a specially designed chair with a seatbelt and the ultrasound operator will be seated to the right and front of them facing the subject Measurements will be taken multiple times during partial gravity or weightlessness and during level flight Subjects are requested to minimize movements during the ultrasound measurements so that accurate measurements can be obtained Also subjects will be encouraged to minimize any movements during periods of increased gravity pull-out pull-up in order to prevent motion sickness
After the data collection is completed subjects will be disconnected from the hardware and electrodes can be removed While subjects may experience fatigue tiredness and motion sickness from participating in parabolic flight there will be no direct effects from the ultrasound measurements except for perhaps skin irritation from the electrodes
During the consent process prior to collection of video or still images we will ask for consent as designated on the Research Consent Form Novespace will photograph or film participants in Novespace facilities including the aircraft and use those images for the purposes of promotion and communication Also photos or video recordings of test subjects may be collected by the investigator team during the experiment These photos may be used in future presentations or publications to demonstrate procedures used during the flight study
Anti-motion sickness medication is distributed to flying participants at their discretion Participants board the Airbus A310 aircraft fasten seatbelts for takeoff After takeoff the pilots fly the aircraft to a specific air zone where the parabolas will take place With other members of the participants group participants will then move to the area of the cabin in which data will be collected Participants will receive instructions from Novespace to maintain safety during the parabolic flight
The aircraft will fly in parabolas that initially produce increased gravity 18-G hypergravity followed by 20-50 second periods of partial gravity or weightlessness After that there will be another pull-up hypergravity to complete the parabola The plane then will fly in normal horizontal flight for a few minutes before repeating the parabolic flight path again The pilots will perform this sequence of maneuvers many times The number of times the level of reduced gravity and the order of reduced gravity exposures will depend upon the flight plan for that day Subjects will be informed of the flight plan in the pre-mission briefing conducted by Novespace Flights which produce partial gravity 025- 050- and 075-gravity generally will consist of 31 parabolas at least 10 parabolas at each gravity level and flights that produce weightlessness generally will consist of 16 parabolas The total flight time from take-off to landing is approximately 2-3 hours
During the flight subjects will be seated in a specially designed chair with a seatbelt and the ultrasound operator will be seated to the right and front of them facing the subject Measurements will be taken multiple times during partial gravity or weightlessness and during level flight Subjects are requested to minimize movements during the ultrasound measurements so that accurate measurements can be obtained Also subjects will be encouraged to minimize any movements during periods of increased gravity pull-out pull-up in order to prevent motion sickness
After the data collection is completed subjects will be disconnected from the hardware and electrodes can be removed While subjects may experience fatigue tiredness and motion sickness from participating in parabolic flight there will be no direct effects from the ultrasound measurements except for perhaps skin irritation from the electrodes
During the consent process prior to collection of video or still images we will ask for consent as designated on the Research Consent Form Novespace will photograph or film participants in Novespace facilities including the aircraft and use those images for the purposes of promotion and communication Also photos or video recordings of test subjects may be collected by the investigator team during the experiment These photos may be used in future presentations or publications to demonstrate procedures used during the flight study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None