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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581295
First Posted: December 27, 2007
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  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: Diffuse optical spectroscopy

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

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, 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 ]

Enrollment: 93
Study Start Date: March 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
trauma
Diffuse optical spectroscopy measurment
Device: Diffuse optical spectroscopy
Diffuse optical spectroscopy measurment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581295


Locations
United States, California
Beckman Laser Institute,University of California, Irvine
Irvine, California, United States, 92612
Trauma/Critical Care Units, UCI Medical Center
Orange, California, United States, 92686
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Michael E Lekawa, M.D Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Michael E. Lekawa, MD Chief, Division of Trauma/Critical Care Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581295     History of Changes
Other Study ID Numbers: NIH-LAMMP-2013-9435
First Submitted: December 19, 2007
First Posted: December 27, 2007
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
internal bleeding
changes in tissue perfusion

Additional relevant MeSH terms:
Wounds and Injuries