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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00581295
Other study ID # 20139435
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2007
Est. completion date April 2011

Study information

Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Diffuse optical spectroscopy
Diffuse optical spectroscopy measurment

Locations

Country Name City State
United States Beckman Laser Institute,University of California, Irvine Irvine California
United States Trauma/Critical Care Units, UCI Medical Center Orange California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions. 5 to 60 seconds
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