Muscle Oxygenation and Skin Pigmentation

Sponsor
Emory University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00747162
Collaborator
(none)
0
1
1
6
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Measure of muscle oxygenation
  • Device: Skin pigmentation determination
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Correlation Between Muscle Oxygenation and Skin Pigmentation
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Measure from The INVOS cerebral oximeter and DermaSpectrometer [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Grady Healthcare System Atlanta Georgia United States 30303

Sponsors and Collaborators

  • Emory University

Investigators

  • Principal Investigator: Thomas J. Moore, MD, Emory University, Department of Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Moore, Assistant Professor, Emory University
ClinicalTrials.gov Identifier:
NCT00747162
Other Study ID Numbers:
  • IRB00009004
First Posted:
Sep 4, 2008
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Thomas Moore, Assistant Professor, Emory University

Study Results

No Results Posted as of Nov 27, 2013