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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.

Sponsors and Collaborators: University of California, Irvine
Trauma/Critical Care unit, UCI Medical Center, Orange
Beckman Laser Institute Medical Clinic
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581295
  Purpose

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.


Condition Intervention
Trauma
Device: DOS

MedlinePlus related topics:   Injuries   Wounds  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   315
Study Start Date:   March 2007
Estimated Study Completion Date:   July 2012
Estimated Primary Completion Date:   July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1 Device: DOS
DOS

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Trauma/Critically Care Patients


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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581295

Locations
United States, California
Trauma/Critical Care Units, UCI Medical Center    
      Orange, California, United States, 92686
Beckman Laser Institute,University of California, Irvine    
      Irvine, California, United States, 92612

Sponsors and Collaborators
University of California, Irvine
Trauma/Critical Care unit, UCI Medical Center, Orange
Beckman Laser Institute Medical Clinic

Investigators
Principal Investigator:     Michael E Lekawa, M.D     Beckman Laser Institute    
  More Information

Responsible Party:   Beckman Laser Institute ( Michale Lekawa, M.D )
Study ID Numbers:   FA9550-04-1-0101, 257;CFD, P41-RR01192;NIH-LAMMP
First Received:   December 19, 2007
Last Updated:   May 22, 2008
ClinicalTrials.gov Identifier:   NCT00581295
Health Authority:   United States: Institutional Review Board

Keywords provided by University of California, Irvine:
internal bleeding  
changes in tissue perfusion  

Study placed in the following topic categories:
Wounds and Injuries
Hemorrhage

Additional relevant MeSH terms:
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 03, 2008




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