Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by J&M Shuler.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
J&M Shuler
ClinicalTrials.gov Identifier:
NCT01283451
First received: January 24, 2011
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Acute Compartment Syndrome
Behavioral: Muscle contraction
Phase 1

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Resource links provided by NLM:


Further study details as provided by J&M Shuler:

Primary Outcome Measures:
  • Near infrared spectroscopy [ Time Frame: <30 minutes ] [ Designated as safety issue: No ]
    NIRS values will be measured before and after muscle fatigue


Estimated Enrollment: 63
Groups/Cohorts Assigned Interventions
Exercise
NIRS values of all participants will be measured at baseline and following each 30-60 second exercise.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283451

Locations
United States, Georgia
Athens Orthopedic Clinic, PA
Athens, Georgia, United States, 30606
Sponsors and Collaborators
J&M Shuler
Investigators
Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic, PA
  More Information

No publications provided

Responsible Party: Michael Shuler, J&M Shuler
ClinicalTrials.gov Identifier: NCT01283451     History of Changes
Other Study ID Numbers: NIRS-01
Study First Received: January 24, 2011
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by J&M Shuler:
near-infrared spectroscopy

Additional relevant MeSH terms:
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014