Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

NCT ID: NCT01284023

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.

Detailed Description

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Conditions

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Acute Compartment Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Controls

Uninjured volunteers

Shaving

Intervention Type OTHER

Male patients will have the leg hair under each sensor site shaved, using an electric razor, and near infrared spectroscopy monitored for an additional 15 minutes

Interventions

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Shaving

Male patients will have the leg hair under each sensor site shaved, using an electric razor, and near infrared spectroscopy monitored for an additional 15 minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* over 18 years old

Exclusion Criteria

* any current traumatic lower or upper extremity injury
* unwilling or unable to provide written informed consent
* history of any anatomy-altering injury or procedure to the upper or lower extremity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nonin Medical, Inc

INDUSTRY

Sponsor Role collaborator

J&M Shuler

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Shuler, MD

Role: PRINCIPAL_INVESTIGATOR

Athens Orthopedic Clinic, PA

Locations

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Athens Orthopedic Clinic, PA

Athens, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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NIRS-02

Identifier Type: -

Identifier Source: org_study_id

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