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Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients

This study is enrolling participants by invitation only.
Information provided by University of California, Irvine

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Descriptive Information Fields
Brief Title  Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
Official Title  Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
Brief Summary

Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze.

In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation.

Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

Detailed Description

The research' want to monitor tissue perfusion and indicators of tissue damage and viability in critically ill patients by using DOS.

Non-invasive Optical Techniques DOS,near-infrared diffuse optical spectroscopy (NIR-DOS.

NIR-DOS provides functional physiologic tissue/organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. The application of frequency-domain photon migration analysis (FDPM) to NIRS allows independent measurements of tissue absorption and scattering properties at depths of 1 cm or more below the skin surface.

Such capabilities will improve early diagnosis, detection, optimization of therapy, assessment of adequacy of resuscitation, and alteration in management plans for all of these critical conditions.

Study Phase
Study Type  Observational
Study Design  Case-Only, Prospective
Primary Outcome Measure  The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions. [ Time Frame: 5 to 60 seconds ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Trauma
Intervention  Device: DOS
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  315
Start Date  March 2007
Completion Date July 2012
Eligibility Criteria 

Inclusion Criteria:

  • Adult age 18 years or older, male or female
  • Trauma/Critical Care patient

Exclusion Criteria:

  • Subject is not Trauma/Critical Care patient
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00581295
Organization ID FA9550-04-1-0101
Secondary IDs †† 257;CFD, P41-RR01192;NIH-LAMMP
Study Sponsor  University of California, Irvine
Collaborators †† Trauma/Critical Care unit, UCI Medical Center, Orange
Beckman Laser Institute Medical Clinic
Investigators 
Principal Investigator:     Michael E Lekawa, M.D     Beckman Laser Institute    
Information Provided By University of California, Irvine
Verification Date May 2008
First Received Date  December 19, 2007
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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