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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01283451
Other study ID # NIRS-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date December 2016

Study information

Verified date August 2018
Source J&M Shuler
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18-75 years old

- no current extremity injuries

- willing to provide written informed consent

Exclusion Criteria:

- history of any anatomy-altering surgery to the extremity in question

- history of peripheral vascular disease

- history of pulmonary disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Muscle contraction
Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.

Locations

Country Name City State
United States Athens Orthopedic Clinic, PA Athens Georgia

Sponsors (1)

Lead Sponsor Collaborator
J&M Shuler

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Near infrared spectroscopy NIRS values will be measured before and after muscle fatigue <30 minutes
See also
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