Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01284023
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2011-01-25
Brief Title:
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Sponsor:
JM Shuler
Organization:
JM Shuler
Study Overview
Official Title:
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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:
Acute compartment syndrome ACS is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the bodys ability to provide blood to the muscle of the leg This condition cuts off blood flow to the leg Left untreated the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation Near-infrared spectroscopy NIRS-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome by observing this device in uninjured subjects
Detailed Description:
None
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