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

Hemorrhagic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581204
• Other study ID #: 20065191
• Status: Completed
• Start date: December 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock, Hemorrhagic

Intervention

Device:
• Near-Infrared Diffuse Optical Spectroscopy
Early predictor of hemorrhagic shock

Locations

Country	Name	City	State
United States	Beckman Laser Institute,University of California, Irvine	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early predictor of shock	The near-infrared diffuse optical spectroscopy measure tissues properties	5 to 60 seconds.