Muscle Oxygenation and Skin Pigmentation

NCT00747162 | Withdrawn Phase 4

• 1 other identifier: IRB00009004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Oxygenation; Skin Pigmentation

Keywords

Compartment Syndrome; Muscle Oxygenation; Skin Pigmentation

Outcome Measures

Primary Outcomes (1)

• Measure from The INVOS cerebral oximeter and DermaSpectrometer

  1 day

Study Arms (1)

1

EXPERIMENTAL

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.

Device: Measure of muscle oxygenation; Device: Skin pigmentation determination

Interventions

Measure of muscle oxygenation DEVICE

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

1

Skin pigmentation determination DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Healthcare System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders; Compartment Syndromes

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas J. Moore, MD

  Emory University, Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)