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

December 19, 2007
December 26, 2012
December 2011
December 2011   (final data collection date for primary outcome measure)
provide information on physiologic status [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581204 on ClinicalTrials.gov Archive Site
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Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans
Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Army Medical Center, civilian and military

Hemorrhagic Shock
Device: NIR/DOS
NIR/DOS measurements
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581204
LAMMP RR-01192
No
Montana Compton, University of California, Irvine
Montana Compton
  • Brooke Army Medical Center
  • Beckman Laser Institute University of California Irvine
Principal Investigator: Matthew Brenner, M.D Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP