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.

Study Overview

• Status: Completed
• Conditions: Hemorrhagic Shock
• Intervention / Treatment: 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
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Beckman Laser Institute,University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Army Medical Center, civilian and military

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic Tool; Near-Infrared Diffuse Optical Spectroscopy Imaging	Device: Near-Infrared Diffuse Optical Spectroscopy; Early predictor of hemorrhagic shock; Other Names: Near-Infrared Diffuse Optical Spectroscopy Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early predictor of shock	The near-infrared diffuse optical spectroscopy measure tissues properties	5 to 60 seconds.

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Beckman Laser Institute University of California Irvine; Brooke Army Medical Center
• Investigators: Principal Investigator: Matthew Brenner, M.D, Beckman Laser Institute University of California Irvine

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: trauma situations; Lower Body Negative Pressure (LBNP)
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Shock; Shock, Hemorrhagic
• Other Study ID Numbers: 20065191