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Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

This study is enrolling participants by invitation only.
Information provided by University of California, Irvine

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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.

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.

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:

  • Healthy nonsmoking normotensive males or females.
  • Age 18 to 55 years old, Military or civilian.
  • Active duty military members who are 17 years old

Exclusion Criteria:

  • Age <18 and >55 years, except for 17 year old active duty military members.
  • History of hyperthyroidism,hypertension, cardiovascular abnormalitY, respiratory illnesses,anaphylaxis,pre-syncopal/syncopal episodes,abnormal blood clotting,
  • Taking drugs to alter autonomic function
  • History of alcohol or drug abuse
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
Investigators 
Principal Investigator:     Matthew Brenner, M.D     Beckman Laser Institute Medical Clinic    
Information Provided By University of California, Irvine
Verification Date March 2008
First Received Date  December 19, 2007
Last Updated Date March 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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