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Muscle Oxygenation and Skin Pigmentation

NCT ID: NCT00747162

Last Updated: 2013-11-27

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-02-28

Brief Summary

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The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Additional information including diseases such as diabetes and vascular disorders will be recorded. Social demographics including alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could also contribute to cardiovascular diseases. The skin pigmentation of each subject will be recorded. Two different methods will be used for this measurement. Each patient will be graded on a six point scale as described by Young (Young, 1997). Additionally, each subject will have their skin measured using a reflectance colorimeter. The colorimeter, DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of light reflected off the skin. By measuring the light reflectance, the skin pigmentation can be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. Using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI) will be used for all measurements.

Detailed Description

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Conditions

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Muscle Oxygenation Skin Pigmentation

Keywords

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Compartment Syndrome Muscle Oxygenation Skin Pigmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

We will use The INVOS cerebral oximeter to determine oxygen content in the healthy muscle. In addition, we will use a the DermaSpectrometer to determine if there are differences in our readings according to skin color.

Group Type EXPERIMENTAL

Measure of muscle oxygenation

Intervention Type DEVICE

The investigators will use an INVOS oxymeter for muscle oxygenation measure.

Skin pigmentation determination

Intervention Type DEVICE

The investigators will use a DermaSpectrometer to get a reading from subjects' skin color

Interventions

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Measure of muscle oxygenation

The investigators will use an INVOS oxymeter for muscle oxygenation measure.

Intervention Type DEVICE

Skin pigmentation determination

The investigators will use a DermaSpectrometer to get a reading from subjects' skin color

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or Female between the ages of 18 and 75 years old
* Subjects that have no lower extremity injuries.
* Subject who are classified as being either light or dark skin pigmentation.
* Subjects willing to participate in the study.

Exclusion Criteria

* Patients with previous injury to either lower extremity
* Patients with previously diagnosed vascular disease or insufficiency
* Patients with pulmonary insufficiency or severe pulmonary injury
* Patients not willing to consent to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Moore

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas J. Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University, Department of Orthopaedics

Locations

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Grady Healthcare System

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00009004

Identifier Type: -

Identifier Source: org_study_id