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

Completed

• Conditions: Hemorrhagic Shock
• Interventions: Device: Near-Infrared Diffuse Optical Spectroscopy

• Registration Number: NCT00581204
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic Tool	Near-Infrared Diffuse Optical Spectroscopy	Near-Infrared Diffuse Optical Spectroscopy Imaging

Primary Outcome Measures

Name	Time	Method
Early predictor of shock	5 to 60 seconds.	The near-infrared diffuse optical spectroscopy measure tissues properties

Trial Locations

Locations (1)

Beckman Laser Institute,University of California, Irvine; 🇺🇸 Irvine, California, United States