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CompletedNCT00581295Updated Nov 1, 2022

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

An observational study in Trauma, sponsored by University of California, Irvine. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by University of California, Irvine · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
93
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trauma

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Keywords

  • internal bleeding
  • changes in tissue perfusion
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 93 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Trauma/Critically Care Patients

Inclusion criteria

  • Adult age 18 years or older, male or female
  • Trauma/Critical Care patient

Exclusion criteria

Exclusion Criteria:

  • Subject is not Trauma/Critical Care patient
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
93 participants (actual)

Groups and cohorts

  • trauma

    Diffuse optical spectroscopy measurment

    Device: Diffuse optical spectroscopy

Interventions

  • DeviceDiffuse optical spectroscopy

    Diffuse optical spectroscopy measurment

06

What researchers measure

Primary outcomes

  1. The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions.

    Time frame: 5 to 60 seconds

07

Study locations

2 sites
  • Beckman Laser Institute,University of California, Irvine
    Irvine, California 92612, United States
  • Trauma/Critical Care Units, UCI Medical Center
    Orange, California 92686, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00581295
Lead sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
Responsible party
Beckman Laser Institute and Medical Center (Michael E. Lekawa, MD Chief, Division of Trauma/Critical Care Surgery, University of California, Irvine) — Principal investigator
First posted
Dec 27, 2007
Start date
Mar 2007
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Nov 1, 2022

Study contacts

Michael E Lekawa, M.D
principal investigator · Beckman Laser Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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