Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | October 28, 2011 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581295 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients | ||||
| Official Title ICMJE | Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients | ||||
| Brief 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. |
||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Trauma/Critically Care Patients |
||||
| Condition ICMJE | Trauma | ||||
| Intervention ICMJE | Device: DOS
DOS |
||||
| Study Group/Cohort (s) | trauma
Intervention: Device: DOS |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 93 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00581295 | ||||
| Other Study ID Numbers ICMJE | LAMMP DOS -RR-01192-29 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||
| Study Sponsor ICMJE | Montana Compton | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of California, Irvine | ||||
| Verification Date | October 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||