Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206031
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-04
Brief Title:
Intraosseous Doppler Ultrasonography to Study Skeletal Physiology Exploratory Study Before Use in Space Physiology
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Use of Intraosseous Doppler Ultrasonography to Study Skeletal Physiology - Echo-Os Study Exploratory Study Before Its Use in Space Physiology
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Echo-Os
Brief Summary:
Use of intraosseous Doppler ultrasonography to study skeletal physiology Echo-Os Study Exploratory study before its use in space physiology
Bones have a complex vascular network providing nutrients and oxygen to bone cells The physiology of intraosseous blood circulation remains very little known to date particularly in human Human bone vascularization studying is very difficult because of a lack of simple tools for functional exploration of bone vascular perfusion For blood flow studies ultrasonography is best suited allowing for dynamic non-invasive measures Bone has until now been considered to stop ultrasound and therefore prevent any intraosseous measurements From a physics viewpoint bones conduct ultrasound waves well but they are reflected differently compared to soft tissues A specific analysis of the ultrasound returned by the bone using specific correction factors is therefore needed to interpret ultrasound signals reconstruct an anatomical image and extract physiological information The system proposed in this study combines standard conventional low-frequency ultrasound probes with a specific analysis of ultrasound wave reflection This system makes it possible to reconstruct an anatomical bone image and record the pulsatile signal of intraosseous vascular perfusion The investigators will use this system to study the vascular reactivity induced by different physiological maneuvers
This protocol proposes to study the following mechanisms of blood flow regulation at the level of tibia cortical bone flow-mediated dilation induced by endothelium with arterial occlusion test vasoconstriction induced by sympathetic activation with static handgrip test and vasoconstriction induced by veno-arteriolar reflex with venous occlusion test This is a pilot study in physiology performed with healthy volunteers This study will verify whether our intraosseous ultrasound system can properly measure physiological responses expected during these maneuvers This protocol will also establish links between perfusion and bone architecture at tibial level
Bones have a complex vascular network providing nutrients and oxygen to bone cells The physiology of intraosseous blood circulation remains very little known to date particularly in human Human bone vascularization studying is very difficult because of a lack of simple tools for functional exploration of bone vascular perfusion For blood flow studies ultrasonography is best suited allowing for dynamic non-invasive measures Bone has until now been considered to stop ultrasound and therefore prevent any intraosseous measurements From a physics viewpoint bones conduct ultrasound waves well but they are reflected differently compared to soft tissues A specific analysis of the ultrasound returned by the bone using specific correction factors is therefore needed to interpret ultrasound signals reconstruct an anatomical image and extract physiological information The system proposed in this study combines standard conventional low-frequency ultrasound probes with a specific analysis of ultrasound wave reflection This system makes it possible to reconstruct an anatomical bone image and record the pulsatile signal of intraosseous vascular perfusion The investigators will use this system to study the vascular reactivity induced by different physiological maneuvers
This protocol proposes to study the following mechanisms of blood flow regulation at the level of tibia cortical bone flow-mediated dilation induced by endothelium with arterial occlusion test vasoconstriction induced by sympathetic activation with static handgrip test and vasoconstriction induced by veno-arteriolar reflex with venous occlusion test This is a pilot study in physiology performed with healthy volunteers This study will verify whether our intraosseous ultrasound system can properly measure physiological responses expected during these maneuvers This protocol will also establish links between perfusion and bone architecture at tibial level
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02403-42 | OTHER | ANSM | None |