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: June 10, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Hemorrhagic Shock
Device: Near-Infrared Diffuse Optical Spectroscopy

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:


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

Primary Outcome Measures:
  • Early predictor of shock [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]
    The near-infrared diffuse optical spectroscopy measure tissues properties


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)
Groups/Cohorts Assigned Interventions
Diagnostic Tool
Near-Infrared Diffuse Optical Spectroscopy Imaging
Device: Near-Infrared Diffuse Optical Spectroscopy
Early predictor of hemorrhagic shock
Other Name: Near-Infrared Diffuse Optical Spectroscopy Imaging

Detailed Description:

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.

  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
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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
University of California, Irvine
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: Beckman Laser Institute and Medical Center, Matthew Brenner, M.D.,Department of Pulmonary and Critical Care Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581204     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-5191
Study First Received: December 19, 2007
Last Updated: June 10, 2015
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, Hemorrhagic
Hemorrhage
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on July 01, 2015