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):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581204
First received: December 19, 2007
Last updated: August 5, 2015
Last verified: August 2015

December 19, 2007
August 5, 2015
December 2011
December 2011   (final data collection date for primary outcome measure)
Early predictor of shock [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]
The near-infrared diffuse optical spectroscopy measure tissues properties
provide information on physiologic status [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]
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

The purpose for this study is to measure the physiology of human undergoing a Lower Body Negative Pressure usea non-invasive low-power optical technique, near-infrared diffuse optical spectroscopy measurement and compare these measurement to standard monitoring procedures delineated in the Brooke Army Medical Center.

The Brooke Army Medical Center can use near-infrared diffuse optical spectroscopy to provide functional physiologic tissue and organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. Monitoring for the onset of circulatory shock in a wounded soldier on the battlefield is typically performed by measurement of arterial blood pressure, arterial oxygen saturation, or simple auscultation of the pulse. 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.

The near-infrared diffuse optical spectroscopy can measure tissue regions deeper below the skin surface and reports on larger tissue volumes in muscle and brain. The near-infrared diffuse optical spectroscopy instrument generate harmless amounts of low-level non-ionizing near-infrared ligh can measure the tissue absorption and scattering properties at depths of 1 cm or more below the skin surface include larger tissue volumes in muscle and brain. The absorption properties of tissue provide and can determine absolute concentrations of deoxygenated hemoglobin, oxygenated hemoglobin, and water, as well as the total hemoglobin saturation.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Army Medical Center, civilian and military
Hemorrhagic Shock
Device: Near-Infrared Diffuse Optical Spectroscopy
Early predictor of hemorrhagic shock
Other Name: Near-Infrared Diffuse Optical Spectroscopy Imaging
Diagnostic Tool
Near-Infrared Diffuse Optical Spectroscopy Imaging
Intervention: Device: Near-Infrared Diffuse Optical Spectroscopy
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   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581204
NIH-LAMMP-2006-5191
No
Not Provided
Not Provided
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
  • 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
August 2015

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