Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279897
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-07
Brief Title:
LBNP Tolerance With Skin Warming After Exercise Cold Stress
Sponsor:
University of Colorado Colorado Springs
Organization:
University of Colorado Colorado Springs
Study Overview
Official Title:
Skin Rewarming After Exercise Cold Stress and Tolerance to Simulated Blood Loss
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold
Detailed Description:
Individuals who have experienced a hemorrhagic insult are often wrapped in a warm blanket In individuals who have exercise in a cold environment it is unknown how this skin warming influence tolerance to simulated blood loss and whether there is an optimal temperature to warm the skin up to in order to lower blood pressure permissive hypotension
After an initial study visit to examine exercise capacity Visit 1 participants will complete four trials Visits 2 through 5 After exercise in a cold environment participants will have cold skin temperatures 82F Visit 2 Researchers will examine how increasing skin temperature to normal 90F Visit 3 warm 93F Visit 4 and hot 95F Visit 5 influences arterial blood pressure and tolerance to simulated blood loss compared to when the skin remains cold
This project will test the hypothesis that skin rewarming to 95F lowers arterial blood pressure without impairing tolerance to simulated blood loss lower body negative pressure LBNP relative to when the skin is kept cold 82F
Primary data include core and skin temperatures arterial blood pressure and LBNP tolerance time Secondary variables include skin blood flow and heart rate After completing visit 1 first all participants will complete visits 2 through 5 in a randomized order and participants are blinded The order will be counterbalanced between participants
After an initial study visit to examine exercise capacity Visit 1 participants will complete four trials Visits 2 through 5 After exercise in a cold environment participants will have cold skin temperatures 82F Visit 2 Researchers will examine how increasing skin temperature to normal 90F Visit 3 warm 93F Visit 4 and hot 95F Visit 5 influences arterial blood pressure and tolerance to simulated blood loss compared to when the skin remains cold
This project will test the hypothesis that skin rewarming to 95F lowers arterial blood pressure without impairing tolerance to simulated blood loss lower body negative pressure LBNP relative to when the skin is kept cold 82F
Primary data include core and skin temperatures arterial blood pressure and LBNP tolerance time Secondary variables include skin blood flow and heart rate After completing visit 1 first all participants will complete visits 2 through 5 in a randomized order and participants are blinded The order will be counterbalanced between participants
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