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Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by J&M Shuler.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283451
First Posted: January 26, 2011
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J&M Shuler
  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 ]
    NIRS values will be measured before and after muscle fatigue


Estimated Enrollment: 63
Study Start Date: January 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: J&M Shuler
ClinicalTrials.gov Identifier: NCT01283451     History of Changes
Other Study ID Numbers: NIRS-01
First Submitted: January 24, 2011
First Posted: January 26, 2011
Last Update Posted: September 9, 2015
Last Verified: September 2015

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

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