Muscle Oxygenation and Skin Pigmentation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Muscle Oxygenation Skin Pigmentation |
Device: Measure of muscle oxygenation Device: Skin pigmentation determination |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Correlation Between Muscle Oxygenation and Skin Pigmentation |
- Measure from The INVOS cerebral oximeter and DermaSpectrometer [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Device: Measure of muscle oxygenation
The investigators will use an INVOS oxymeter for muscle oxygenation measure.
Device: Skin pigmentation determination
The investigators will use a DermaSpectrometer to get a reading from subjects' skin color
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Georgia | |
| Grady Healthcare System | |
| Atlanta, Georgia, United States, 30303 | |
| Principal Investigator: | Thomas J. Moore, MD | Emory University, Department of Orthopaedics |
More Information
No publications provided
| Responsible Party: | Thomas Moore, Assistant Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00747162 History of Changes |
| Other Study ID Numbers: | 9004 |
| Study First Received: | August 27, 2008 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Compartment Syndrome Muscle Oxygenation Skin Pigmentation |
ClinicalTrials.gov processed this record on May 16, 2013