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OpenTrials
Completed

NCT Number: NCT01283451

Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens Orthopedic Clinic, PA

Athens, Georgia, 30606, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Near infrared spectroscopy

    Time frame: <30 minutes

    NIRS values will be measured before and after muscle fatigue

Sponsors and collaborators

Lead sponsor

J&M Shuler

Industry

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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