Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467825
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-07
Brief Title:
Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent
Sponsor:
National Aeronautics and Space Administration NASA
Organization:
National Aeronautics and Space Administration NASA
Study Overview
Official Title:
Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent
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:
Lunar OI
Brief Summary:
The purpose of Lunar OI Orthostatic Intolerance is to determine if there are differences between males and females in tolerance to and cardiovascular responses during different angles of head-up tilt simulating gravity levels less than or equal to Earths gravity Also this study will determine if a gradient compression garment affects tolerance to tilting and the cardiovascular stress at different tilt angles Males and females are being identified by biological sex This will be a two-phased study design In Phase I we will determine whether there are differences in the development of signs or symptoms of orthostatic intolerance between males and females when tilted head up on a table to different angles to simulate gravity levels that astronauts may experience when landing on or launching from the surface of the Moon In Phase II the tilt tests simulating the same gravity levels from Phase I will be repeated but a custom-made lower-body compression garment will be worn to see if wearing the garment affects the development of orthostatic intolerance For both study phases before tilting a drug will be administered to reduce the amount fluid in the blood plasma to levels similar to that experienced by astronauts during spaceflight
Detailed Description:
Phase I Visit one Alpha 1A
OIG Orthostatic Intolerance Garment Measurement
Participants will lie supine while torso and anthropometric measurements are acquired The investigators will utilize the same procedures developed and adopted by the Orion Program to obtain foot leg and torso circumference measurements at pre-determined intervals This detailed measurement procedure has shown to be effective at providing precise compression levels at pre-determined anatomical locations The target levels of compression will be verified by the manufacturer using a Hosiery and Allied Trades Research Association HATRA test instrument that is identified in the British Standard for testing compression in elastic stockings
Tilt Familiarization
Participants will be instructed to lie supine without moving throughout the Familiarization tilt test After instrumentation with brachial blood pressure continuous blood pressure monitoring and electrocardiogram ECG for heart rate baseline measures will be obtained for at least 2 minutes while the test is explained Participants will be tilted to 80 head-up and instructed to remain still and quiet After allowing the participant to become familiar with the tilt procedure and the feeling of being upright the bed will be lowered back to horizontal flat and a timer started for a 20-minute supine rest period
Plasma and Blood Volume Measurement
An intravenous IV catheter will be inserted into a vein in the participants arm or hand using standard techniques All blood samples will be obtained using the IV catheter in the participants arm unless it becomes clogged and another IV catheter cannot be placed in another arm or hand vein In this situation blood could be drawn from the participants arm or hand vein using a butterfly needle
Participants will be supine for 20 minutes before this test begins A clip will be placed on the participants nose so that they are breathing only through their mouth Participants will breathe through a mouthpiece connected to a rebreathing circuit containing 100 oxygen which is scrubbed by soda lime to remove carbon dioxide After 5 minutes a 10 mL blood sample will be collected using the IV catheter Thereafter a small amount of carbon monoxide will be added into the breathing circuit and the participant will breathe this mixture of carbon monoxide and oxygen for 10 min Then a second 10 mL blood sample will be obtained Analysis of the blood samples ie hematocrit hemoglobin and carboxyhemoglobin will be used to calculate red blood cell mass plasma volume and total blood volume
Normovolemic Tilt Test at one unit of gravity 1G
This test will be similar to the Tilt Familiarization session but baseline data will be collected for 5 minutes while supine After tilting up participants will remain quiet relaxed and not move for up to 20 minutes or until presyncope Brachial blood pressure will be measured and ultrasound images obtained to quantify stroke volume approximately every minute Blood pressure and ECG will be continuously monitored before during and after the tilt A tilt test will be terminated if any of the following test termination criteria are met sudden drop in heart rate 15 bpm systolic blood pressure 25 mmHg or diastolic blood pressure 15 mmHg significant cardiac arrhythmias such as an ectopic rhythm 4 beats absolute systolic blood pressure 70 mmHg symptoms such as nausea clammy skin profuse sweating pallor light-headedness dizziness or tingling or participant request In the event a tilt test is terminated prior to 20 minutes the participant will be brought to a head-down tilt position until recovered
Visit one Bravo 1B
Plasma Volume Furosemide Infusion
Plasma volume will be measured as described in Phase 1A After the plasma volume test is complete a 20 mg of Furosemide will be administered intravenously This dose has been demonstrated to produce plasma volume losses similar to spaceflight and bedrest An oral potassium supplement of 20 mEq Milliequivalent will be given as a prophylactic prior to the furosemide infusion
Induction of Hypovolemia
Following Furosemide infusion participants will remain in the CVL Cardiovascular and Vision Laboratory and be observed while remaining seated except for bathroom trips for 2 hours During this time urine volume and periodic blood pressure will be obtained Participants will self-collect urine using urine collection bottles and provide to the test operator to document the time of urine collection and volume produced Participants will be given a standardized volume of water at intervals throughout the study day Participants will be provided snacks as needed throughout the duration of their stay in the laboratory
Hypovolemic Tilt Tests 1-G 075-G 050-G
Following the 2-hour period for diuresis to develop participants will undergo 3 tilt tests 80 50 and 30 head-up tilt for up to 20 minutes each to simulate 1-G 075-G and 050-G exposures The tilt tests will occur in a random order and participants will remain supine for 20 minutes to fully recover between tests The timing monitoring and test termination criteria will be identical to that described in Normovolemic Tilt Test 1G above Immediately prior to each tilt test a blood sample 5 mL will be drawn using the IV catheter and analyzed for hematocrit and hemoglobin concentration which will then be used to calculate the change in plasma volume since the baseline test Alternatively if the IV becomes clogged and another IV cannot be placed these blood samples could be drawn from an arm or hand vein using a butterfly needle 5 mL or by pricking the finger 80 μL
Phase II Visit two Alpha 2A
OIG Fit Check
Participants will don their custom OIG garments to ensure there were no errors in garment development
Visit two Bravo 2B
Plasma Volume Furosemide Infusion Participants will complete the same testing protocol as occurred in Phase 1B
Induction of Hypovolemia
Participants will complete the same testing protocol as occurred in Phase 1B
Hypovolemic Tilt Tests 1-G 075-G 050-G OIG
Following the 2-hour period for diuresis to develop participants will don their custom-made OIG and assume the supine posture for 20 minutes prior to starting the first tilt test The order of the 3 tilt tests 80 50 and 30 head-up tilt will be the same order as occurred in Phase 1B Hypovolemic Tilt Tests 1-g 075-G 050-G
Visits 2A and 2B can be combined
OIG Orthostatic Intolerance Garment Measurement
Participants will lie supine while torso and anthropometric measurements are acquired The investigators will utilize the same procedures developed and adopted by the Orion Program to obtain foot leg and torso circumference measurements at pre-determined intervals This detailed measurement procedure has shown to be effective at providing precise compression levels at pre-determined anatomical locations The target levels of compression will be verified by the manufacturer using a Hosiery and Allied Trades Research Association HATRA test instrument that is identified in the British Standard for testing compression in elastic stockings
Tilt Familiarization
Participants will be instructed to lie supine without moving throughout the Familiarization tilt test After instrumentation with brachial blood pressure continuous blood pressure monitoring and electrocardiogram ECG for heart rate baseline measures will be obtained for at least 2 minutes while the test is explained Participants will be tilted to 80 head-up and instructed to remain still and quiet After allowing the participant to become familiar with the tilt procedure and the feeling of being upright the bed will be lowered back to horizontal flat and a timer started for a 20-minute supine rest period
Plasma and Blood Volume Measurement
An intravenous IV catheter will be inserted into a vein in the participants arm or hand using standard techniques All blood samples will be obtained using the IV catheter in the participants arm unless it becomes clogged and another IV catheter cannot be placed in another arm or hand vein In this situation blood could be drawn from the participants arm or hand vein using a butterfly needle
Participants will be supine for 20 minutes before this test begins A clip will be placed on the participants nose so that they are breathing only through their mouth Participants will breathe through a mouthpiece connected to a rebreathing circuit containing 100 oxygen which is scrubbed by soda lime to remove carbon dioxide After 5 minutes a 10 mL blood sample will be collected using the IV catheter Thereafter a small amount of carbon monoxide will be added into the breathing circuit and the participant will breathe this mixture of carbon monoxide and oxygen for 10 min Then a second 10 mL blood sample will be obtained Analysis of the blood samples ie hematocrit hemoglobin and carboxyhemoglobin will be used to calculate red blood cell mass plasma volume and total blood volume
Normovolemic Tilt Test at one unit of gravity 1G
This test will be similar to the Tilt Familiarization session but baseline data will be collected for 5 minutes while supine After tilting up participants will remain quiet relaxed and not move for up to 20 minutes or until presyncope Brachial blood pressure will be measured and ultrasound images obtained to quantify stroke volume approximately every minute Blood pressure and ECG will be continuously monitored before during and after the tilt A tilt test will be terminated if any of the following test termination criteria are met sudden drop in heart rate 15 bpm systolic blood pressure 25 mmHg or diastolic blood pressure 15 mmHg significant cardiac arrhythmias such as an ectopic rhythm 4 beats absolute systolic blood pressure 70 mmHg symptoms such as nausea clammy skin profuse sweating pallor light-headedness dizziness or tingling or participant request In the event a tilt test is terminated prior to 20 minutes the participant will be brought to a head-down tilt position until recovered
Visit one Bravo 1B
Plasma Volume Furosemide Infusion
Plasma volume will be measured as described in Phase 1A After the plasma volume test is complete a 20 mg of Furosemide will be administered intravenously This dose has been demonstrated to produce plasma volume losses similar to spaceflight and bedrest An oral potassium supplement of 20 mEq Milliequivalent will be given as a prophylactic prior to the furosemide infusion
Induction of Hypovolemia
Following Furosemide infusion participants will remain in the CVL Cardiovascular and Vision Laboratory and be observed while remaining seated except for bathroom trips for 2 hours During this time urine volume and periodic blood pressure will be obtained Participants will self-collect urine using urine collection bottles and provide to the test operator to document the time of urine collection and volume produced Participants will be given a standardized volume of water at intervals throughout the study day Participants will be provided snacks as needed throughout the duration of their stay in the laboratory
Hypovolemic Tilt Tests 1-G 075-G 050-G
Following the 2-hour period for diuresis to develop participants will undergo 3 tilt tests 80 50 and 30 head-up tilt for up to 20 minutes each to simulate 1-G 075-G and 050-G exposures The tilt tests will occur in a random order and participants will remain supine for 20 minutes to fully recover between tests The timing monitoring and test termination criteria will be identical to that described in Normovolemic Tilt Test 1G above Immediately prior to each tilt test a blood sample 5 mL will be drawn using the IV catheter and analyzed for hematocrit and hemoglobin concentration which will then be used to calculate the change in plasma volume since the baseline test Alternatively if the IV becomes clogged and another IV cannot be placed these blood samples could be drawn from an arm or hand vein using a butterfly needle 5 mL or by pricking the finger 80 μL
Phase II Visit two Alpha 2A
OIG Fit Check
Participants will don their custom OIG garments to ensure there were no errors in garment development
Visit two Bravo 2B
Plasma Volume Furosemide Infusion Participants will complete the same testing protocol as occurred in Phase 1B
Induction of Hypovolemia
Participants will complete the same testing protocol as occurred in Phase 1B
Hypovolemic Tilt Tests 1-G 075-G 050-G OIG
Following the 2-hour period for diuresis to develop participants will don their custom-made OIG and assume the supine posture for 20 minutes prior to starting the first tilt test The order of the 3 tilt tests 80 50 and 30 head-up tilt will be the same order as occurred in Phase 1B Hypovolemic Tilt Tests 1-g 075-G 050-G
Visits 2A and 2B can be combined
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