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.

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Key information

Conditions

Hemorrhagic Shock Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Hemorrhagic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beckman Laser Institute,University of California, Irvine

Irvine, California, 92612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-Infrared Diffuse Optical Spectroscopy

Device

Early predictor of hemorrhagic shock

Other names: Near-Infrared Diffuse Optical Spectroscopy Imaging

Primary outcomes

Early predictor of shock

Time frame: 5 to 60 seconds.

The near-infrared diffuse optical spectroscopy measure tissues properties

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

Beckman Laser Institute University of California Irvine
Brooke Army Medical Center

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Dec 27, 2007
Registry last updated: Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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