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

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581295
First received: December 19, 2007
Last updated: October 28, 2011
Last verified: October 2011
  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

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 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 ]

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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Montana Compton
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Investigators
Principal Investigator: Michael E Lekawa, M.D Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581295     History of Changes
Other Study ID Numbers: LAMMP DOS -RR-01192-29
Study First Received: December 19, 2007
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014