Clinical trial NCT00581204: Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans
Official title: Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhagic Shock
Keywords: trauma situations
Lower Body Negative Pressure (LBNP)
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Army Medical Center, civilian and military

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early predictor of shock
timeFrame: 5 to 60 seconds.
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute,University of California, Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Matthew Brenner, M.D
role: PRINCIPAL_INVESTIGATOR
References: