Muscle Oxygenation and Skin Pigmentation

Phase 4

Withdrawn

• Conditions: Skin Pigmentation; Muscle Oxygenation
• Interventions: Device: Measure of muscle oxygenation; Device: Skin pigmentation determination

• Registration Number: NCT00747162
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Measure of muscle oxygenation	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.
1	Skin pigmentation determination	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.

Primary Outcome Measures

Name	Time	Method
Measure from The INVOS cerebral oximeter and DermaSpectrometer	1 day

Trial Locations

Locations (1)

Grady Healthcare System; 🇺🇸 Atlanta, Georgia, United States