Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633692
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Female Pelvic Blood Flow Under Simulated Microgravity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Female Pelvic Blood Flow Under Simulated Microgravity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spaceflight is characterized by unique physiological adaptations Cardiovascular system response to the microgravity includes major changes During spaceflight body fluids are displaced in the cephalad direction due to changes in gravity resulting in altered vascular dynamics and the redistribution of the blood circulation
As we approach crewed Moon and Mars missions and commercial spaceflights become more frequent understanding the impact of space travel on womens health is crucial Despite the known importance of these vascular dynamics in both clinical and research settings we have limited information on the pelvic blood flow under microgravity Our aim is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry Head down tilt HDT position is an established model in literature for simulated microgravity on Earth
This prospective study will assess pelvic organ blood flow in the supine position after a period of acclimation as a control After completing Doppler measurements in the supine position participant will be placed in the HDT position Following a period of acclimation Doppler measurements will be repeated on the same vesselsDuring both supine and simulated microgravity conditions vital signs ie blood pressure heart rate oxygen saturation will be collected
As we approach crewed Moon and Mars missions and commercial spaceflights become more frequent understanding the impact of space travel on womens health is crucial Despite the known importance of these vascular dynamics in both clinical and research settings we have limited information on the pelvic blood flow under microgravity Our aim is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry Head down tilt HDT position is an established model in literature for simulated microgravity on Earth
This prospective study will assess pelvic organ blood flow in the supine position after a period of acclimation as a control After completing Doppler measurements in the supine position participant will be placed in the HDT position Following a period of acclimation Doppler measurements will be repeated on the same vesselsDuring both supine and simulated microgravity conditions vital signs ie blood pressure heart rate oxygen saturation will be collected
Detailed Description:
Cardiovascular system response to the microgravity includes major changes During spaceflight body fluids are displaced in the cephalad direction due to changes in gravity resulting in altered vascular dynamics and the redistribution of the blood circulation Redistribution of fluids triggers baroreceptor reflex and autonomic response initiates Cardiovascular response to the microgravity environment is affected by gender Women tend to lose more plasma volume and have less peripheral vascular resistance in response to microgravity analogue situations like bed rest
Simulated microgravity leads to increased stiffness and remodeling of the aorta a major vessel supplying blood to the abdomen pelvis and lower extremities Pelvic organs are located in the lower abdomen and have rich blood supply through these major blood vessels and anastomosis Mathematical modeling for microgravity showed a 6 mean flow rate variation in the last part of abdominal aorta Furthermore mean flow rate variations and resistance changed based on the branching arteries such as internal iliac arteries The uterine and ovarian arteries branch from the internal iliac arteries and abdominal aorta respectively Blood supply to an organ and tissue perfusion are vital for the proper functioning of the organs and tissues
As we approach crewed Moon and Mars missions and commercial spaceflights become more frequent understanding the impact of space travel on womens health is crucial Despite the known importance of these vascular dynamics in both clinical and research settings we have limited information on the pelvic blood flow under microgravity Our aim is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry Head down tilt HDT position is an established model in literature for simulated microgravity on Earth
This prospective study will be conducted at Koç University Hospital Adult women of reproductive age 18-44 years undergoing abdominal ultrasound will be recruited Participants will be selected from a cohort presenting for their well-woman visit there will be no additional visits Ultrasound and Doppler spectrometry evaluations will be carried out with convex and linear probes of the GE Loqic S8 device We will assess pelvic organ blood flow in the supine position after a period of acclimation as a control After completing Doppler measurements in the supine position the participant will be placed in the HDT position Following a period of acclimation Doppler measurements will be repeated on the same vessels During both supine and simulated microgravity conditions vital signs ie blood pressure heart rate oxygen saturation will be collected Pre- and post-HDT Doppler measurements will be compared and analyzed
Simulated microgravity leads to increased stiffness and remodeling of the aorta a major vessel supplying blood to the abdomen pelvis and lower extremities Pelvic organs are located in the lower abdomen and have rich blood supply through these major blood vessels and anastomosis Mathematical modeling for microgravity showed a 6 mean flow rate variation in the last part of abdominal aorta Furthermore mean flow rate variations and resistance changed based on the branching arteries such as internal iliac arteries The uterine and ovarian arteries branch from the internal iliac arteries and abdominal aorta respectively Blood supply to an organ and tissue perfusion are vital for the proper functioning of the organs and tissues
As we approach crewed Moon and Mars missions and commercial spaceflights become more frequent understanding the impact of space travel on womens health is crucial Despite the known importance of these vascular dynamics in both clinical and research settings we have limited information on the pelvic blood flow under microgravity Our aim is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry Head down tilt HDT position is an established model in literature for simulated microgravity on Earth
This prospective study will be conducted at Koç University Hospital Adult women of reproductive age 18-44 years undergoing abdominal ultrasound will be recruited Participants will be selected from a cohort presenting for their well-woman visit there will be no additional visits Ultrasound and Doppler spectrometry evaluations will be carried out with convex and linear probes of the GE Loqic S8 device We will assess pelvic organ blood flow in the supine position after a period of acclimation as a control After completing Doppler measurements in the supine position the participant will be placed in the HDT position Following a period of acclimation Doppler measurements will be repeated on the same vessels During both supine and simulated microgravity conditions vital signs ie blood pressure heart rate oxygen saturation will be collected Pre- and post-HDT Doppler measurements will be compared and analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None