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

This study has been completed.
Sponsor:
Collaborators:
Brooke Army Medical Center
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581204
First received: December 19, 2007
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Hemorrhagic Shock
 Device: NIR/DOS

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • provide information on physiologic status [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NIR/DOS
    NIR/DOS measurements
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Army Medical Center, civilian and military

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581204

Locations
United States, California
Beckman Laser Institute,University of California, Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Brooke Army Medical Center
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Matthew Brenner, M.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581204     History of Changes
Other Study ID Numbers: LAMMP RR-01192
Study First Received: December 19, 2007
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
trauma situations
Lower Body Negative Pressure (LBNP)

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Pathologic Processes
Hemorrhage

ClinicalTrials.gov processed this record on June 18, 2013