Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

NCT01283451 | Completed

• 1 other identifier: NIRS-01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Compartment Syndrome

Keywords

near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Near infrared spectroscopy

  NIRS values will be measured before and after muscle fatigue

  <30 minutes

Study Arms (1)

Exercise

NIRS values of all participants will be measured at baseline and following each 30-60 second exercise.

Behavioral: Muscle contraction

Interventions

Muscle contraction BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study sample will consist of healthy volunteers recruited from the principle investigator's private practice.

You may qualify if:

• years old
• no current extremity injuries
• willing to provide written informed consent

You may not qualify if:

• history of any anatomy-altering surgery to the extremity in question
• history of peripheral vascular disease
• history of pulmonary disease

Sponsors & Collaborators

• J&M Shuler: lead

Study Sites (1)

Athens Orthopedic Clinic, PA

Athens, Georgia, 30606, United States

Location

MeSH Terms

Interventions

Muscle Contraction

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Shuler, MD

  Athens Orthopedic Clinic, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)