Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405282
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-04-04
Brief Title:
Weightlessness Associated Cephalad Fluid Shifts The Potential to Evaluate Venous and Lymphatic Dysfunction
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
Official Title:
The Use of Non-Invasive Imaging Devices NIID to Detect Temperature Differentiation and LymphaticVenous Flow to the Head and Neck During Head Down Tilt Position Before and After Manual Lymphatic Drainage The NIID Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
NIID
Brief Summary:
In the weightlessness of space and significant alterations of terrestrial 1 g 1 gravity equivalent head-to-foot hydrostatic pressure gradients astronauts experience a dramatic fluid redistribution of 2 liters from the legs to the head and neck within the first 24-48 hours of flight among other cardiovascular and physiologic system adaptations After only 4 days in the weightlessness of low earth orbit LEO changes can be seen in baroreceptor responsiveness causing orthostatic hypotension upon subsequent return to Earth Fluid shifts may also result in headaches congestion or facial puffiness that can contribute to deteriorating sleep patterns The ability to manage mitigate or offset these fluid shifts is vital to maintain nominal health for short and long duration space flight and potentially improve readaptation to terrestrial gravity or other surface gravity fields such as the moon or Mars Fluid shifts towards the cephalic region during microgravity have been speculated to contribute towards spaceflight associated neuro-ocular syndrome SANS SANS is a distinct microgravity-induced phenomenon of neuro-ophthalmic findings observed in astronauts following long-duration spaceflight including choroidal folds optic disc edema posterior globe flattening refractive shift and cerebral fluid shifts noted to be persistent at 6-month post-flight MRI scans Thus noninvasive approaches to studying real-time fluid shifts in weightlessness could serve as critical areas of research to further SANS study and effective countermeasure protocol development For continuous fluid shift monitoring and management the goal is to establish baseline assessments utilizing real-time point- of-care noninvasive imaging devices NIID
Manual lymphatic drainage MLD therapy reduces lymphatic fluid in the affected limb head and neck to improve function and prevent progression of fluid build-up MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD
The main objectives of this pilot retrospective study were to use NIID to examine temperature differential alterations superficial venous flow patterns head neck upper torso and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree head down tilt HDT validated space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature HDT is the best validated space analogue currently available for evaluation of fluid redistribution in a timely manner
Manual lymphatic drainage MLD therapy reduces lymphatic fluid in the affected limb head and neck to improve function and prevent progression of fluid build-up MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD
The main objectives of this pilot retrospective study were to use NIID to examine temperature differential alterations superficial venous flow patterns head neck upper torso and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree head down tilt HDT validated space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature HDT is the best validated space analogue currently available for evaluation of fluid redistribution in a timely manner
Detailed Description:
Under the influence of standard developmental physiology on the Earths surface 1 g 70 of body fluids reside below the level of the heart The lymphatic system has the capacity and capability to transport fluid from distal to proximal in an upward manner against gravity and tissue pressure gradients via lymphangion contractility leg muscle contraction respiratory and chest wall function thus augmenting a suction effect for pumping lymphatic fluid within the subatmospheric pressure tissue distribution zones the Guyton principle Lymphatic drainage of the head and neck must be assisted by gravity since these regions are above the level of the heart In the weightlessness of space and significant alterations of terrestrial 1 g head-to-foot hydrostatic pressure gradients astronauts experience a dramatic fluid redistribution of 2 liters from the legs to the head and neck within the first 24-48 hours of flight among other cardiovascular and physiologic system adaptations After only 4 days in the weightlessness of LEO changes can be seen in baroreceptor responsiveness causing orthostatic hypotension upon subsequent return to Earth Fluid shifts may also result in headaches congestion or facial puffiness that can contribute to deteriorating sleep patterns The ability to manage mitigate or offset these fluid shifts is vital to maintain nominal health for short and long duration space flight and potentially improve readaptation to terrestrial gravity or other surface gravity fields such as the moon or Mars Fluid shifts towards the cephalic region during microgravity have been speculated to contribute towards spaceflight associated neuro-ocular syndrome SANS SANS is a distinct microgravity-induced phenomenon of neuro-ophthalmic findings observed in astronauts following long-duration spaceflight including choroidal folds optic disc edema posterior globe flattening refractive shift and cerebral fluid shifts noted to be persistent at 6-month post-flight MRI scans Thus noninvasive approaches to studying real-time fluid shifts in weightlessness could serve as critical areas of research to further SANS study and effective countermeasure protocol development For continuous fluid shift monitoring and management the goal is to establish baseline assessments utilizing real-time point-of-care NIID
MLD therapy reduces lymphatic fluid in the affected limb head and neck to improve function and prevent progression of fluid build-up MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD
The main objectives of this pilot retrospective case series were to use 4 standard-of-care NIIDs to examine temperature differential alterations superficial venous flow patterns head neck upper torso and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree HDT space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature We hypothesize that dermal venous and lymphatic flow patterns of the head neck upper torso and ventromedial bundle flow patterns shifted to cephalad dermal interstitial fluid increase and were reversed following MLD therapy in the 6-degree HDT position More specifically MLD therapy could alter lymphatic contractility flow patterns and interstitial fluid in addition to temperature differentials in the 6-degree HDT position
The following imaging devices were used to measure fluid redistribution and temperature in the HDT near-infrared spectroscopy imaging device SnapShotNIR Kent Imaging Calgary Canada to capture perfusion changes through and superficial oxygenation saturation measurements long-wave infrared and wound imaging device WoundVision Scout WoundVision Indianapolis IN to capture thermal images measuring physiological temperature differentiation Lymphatic fluid scanning device LymphScanner Delfin Technologies Miami FL USA to measure percentage water content tissue dielectric constant TDC consistent with lymphatic flow patterns and interstitial fluid alterations related to positioning
MLD therapy reduces lymphatic fluid in the affected limb head and neck to improve function and prevent progression of fluid build-up MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD
The main objectives of this pilot retrospective case series were to use 4 standard-of-care NIIDs to examine temperature differential alterations superficial venous flow patterns head neck upper torso and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree HDT space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature We hypothesize that dermal venous and lymphatic flow patterns of the head neck upper torso and ventromedial bundle flow patterns shifted to cephalad dermal interstitial fluid increase and were reversed following MLD therapy in the 6-degree HDT position More specifically MLD therapy could alter lymphatic contractility flow patterns and interstitial fluid in addition to temperature differentials in the 6-degree HDT position
The following imaging devices were used to measure fluid redistribution and temperature in the HDT near-infrared spectroscopy imaging device SnapShotNIR Kent Imaging Calgary Canada to capture perfusion changes through and superficial oxygenation saturation measurements long-wave infrared and wound imaging device WoundVision Scout WoundVision Indianapolis IN to capture thermal images measuring physiological temperature differentiation Lymphatic fluid scanning device LymphScanner Delfin Technologies Miami FL USA to measure percentage water content tissue dielectric constant TDC consistent with lymphatic flow patterns and interstitial fluid alterations related to positioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None