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

NCT ID: NCT00581204

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Hemorrhagic Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic Tool

Near-Infrared Diffuse Optical Spectroscopy Imaging

Near-Infrared Diffuse Optical Spectroscopy

Intervention Type DEVICE

Early predictor of hemorrhagic shock

Interventions

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Near-Infrared Diffuse Optical Spectroscopy

Early predictor of hemorrhagic shock

Intervention Type DEVICE

Other Intervention Names

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Near-Infrared Diffuse Optical Spectroscopy Imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Matthew Brenner, M.D.,Department of Pulmonary and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Brenner, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Institute,University of California, Irvine

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20065191

Identifier Type: -

Identifier Source: org_study_id

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