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| Descriptive Information Fields | |||||
| Brief Title † | Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans | ||||
| Official Title † | Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans | ||||
| Brief Summary | Hemorrhagic shock is typically identified by the degree of hypotension that develops as a result of blood loss and remains a leading cause of death on the battlefield as well as worldwide. Monitoring for the onset of circulatory shock in a wounded soldier on the battlefield is typically performed by measurement of arterial blood pressure (mean, systolic, diastolic), arterial oxygen saturation (oximetry), or simple auscultation of the pulse (rate and character). Shock is typically recognized by non-specific signs and subjective symptoms such as: cold clammy skin, pallor, weak thready pulse, unstable vital signs, and diminished mentation. Unfortunately, these signs are imprecise, subjective, and inconsistent. Therefore, a definition based on the absence or presence of hypotension can be misleading since it does not represent the underlying problem of or the solution to hemorrhagic shock. The resulting challenge is that shock is easily diagnosed in late stages when therapy is ineffective while early diagnosis is difficult because shock is first recognized by imprecise signs and subjective symptoms. |
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| Detailed Description | The near-infrared diffuse optical spectroscopy (NIR-DOS) developed at the Beckman Laser Institute,UC Irvine, has ability to analyzes tissue regions deeper below the skin surface and reports on larger tissue volumes in muscle and brain. The FDPM DOS instrument generates harmless amounts of low-level non-ionizing NIR ligh. The DOS probe will be applied to the selected sites with standard of care procedure. The measurement will be repeated several times to monitor the physiology. The monitoring will continue intermittently during the period of the experiment. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | provide information on physiologic status [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Hemorrhagic Shock | ||||
| Intervention † | Device: NIR/DOS | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 35 | ||||
| Start Date † | February 2007 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00581204 | ||||
| Organization ID | FA 9550-04-1-0101 | ||||
| Secondary IDs †† | P41-RR01192;NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Brooke Army Medical Center in Fort Sam Houston, Texas Beckman Laser Institute Medical Clinic |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | December 19, 2007 | ||||
| Last Updated Date | March 26, 2008 | ||||
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