- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581295
Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Irvine, California, United States, 92612
- Beckman Laser Institute,University of California, Irvine
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Orange, California, United States, 92686
- Trauma/Critical Care Units, UCI Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult age 18 years or older, male or female
- Trauma/Critical Care patient
Exclusion Criteria:
- Subject is not Trauma/Critical Care patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
trauma
Diffuse optical spectroscopy measurment
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Diffuse optical spectroscopy measurment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions.
Time Frame: 5 to 60 seconds
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5 to 60 seconds
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael E Lekawa, M.D, Beckman Laser Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20139435
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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