Overview

This trial is active, not recruiting.

Condition acute compartment syndrome
Treatment muscle contraction
Phase phase 1
Sponsor J&M Shuler
Start date January 2010
End date December 2016
Trial size 63 participants
Trial identifier NCT01283451, NIRS-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
NIRS values of all participants will be measured at baseline and following each 30-60 second exercise.
muscle contraction
Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.

Primary Outcomes

Measure
Near infrared spectroscopy
time frame: <30 minutes

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
Principal investigator Michael Shuler, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by J&M Shuler.