Muscle Oxygenation and Skin Pigmentation

This study has been withdrawn prior to enrollment.
(incorporated into other study)
Sponsor:
Information provided by (Responsible Party):
Thomas Moore, Emory University
ClinicalTrials.gov Identifier:
NCT00747162
First received: August 27, 2008
Last updated: November 26, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747162

Locations
United States, Georgia
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
  More Information

No publications provided

Responsible Party: Thomas Moore, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00747162     History of Changes
Other Study ID Numbers: IRB00009004
Study First Received: August 27, 2008
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Compartment Syndrome
Muscle Oxygenation
Skin Pigmentation

ClinicalTrials.gov processed this record on July 29, 2014