Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients - Full Text View

Sponsors and Collaborators:	University of California, Irvine Trauma/Critical Care unit, UCI Medical Center, Orange Beckman Laser Institute University of California Irvine Volighten Scientific, Ltd.
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

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

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

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 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:	Sugery Department UCIMC ( Michael Lekawa, M.D )
Study ID Numbers:	LAMMP DOS -RR-01192-29, VOLIGHTEN V-45082
Study First Received:	December 19, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00581295 History of Changes
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
Disorders of Environmental Origin
Hemorrhage

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 06, 2009