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

NCT00581204 | Completed

• 1 other identifier: 20065191
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Shock

Keywords

trauma situations; Lower Body Negative Pressure (LBNP)

Outcome Measures

Primary Outcomes (1)

• Early predictor of shock

  The near-infrared diffuse optical spectroscopy measure tissues properties

  5 to 60 seconds.

Study Arms (1)

Diagnostic Tool

Near-Infrared Diffuse Optical Spectroscopy Imaging

Device: Near-Infrared Diffuse Optical Spectroscopy

Interventions

Near-Infrared Diffuse Optical Spectroscopy DEVICE

Early predictor of hemorrhagic shock

Also known as: Near-Infrared Diffuse Optical Spectroscopy Imaging

Diagnostic Tool

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Army Medical Center, civilian and military

You may qualify if:

• Healthy nonsmoking normotensive males or females.
• Age 18 to 55 years old, Military or civilian.
• Active duty military members who are 17 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Brooke Army Medical Center: collaborator
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute,University of California, Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Brenner, M.D

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matthew Brenner, M.D.,Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 27, 2007
• Study Start: December 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)