Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Acute Compartment Syndrome Clinical Trial

Official title:

Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283451
• Other study ID #: NIRS-01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes

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