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

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ClinicalTrials.gov Identifier: NCT00581204
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : February 10, 2017
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

Brief Summary:

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 or disease Intervention/treatment
Hemorrhagic Shock Device: Near-Infrared Diffuse Optical Spectroscopy

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.

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans
Study Start Date : December 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Early predictor of shock [ Time Frame: 5 to 60 seconds. ]
    The near-infrared diffuse optical spectroscopy measure tissues properties



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
trauma situations
Lower Body Negative Pressure (LBNP)

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