Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans - Full Text View

Purpose

Hemorrhagic shock is typically identified by the degree of hypotension that develops as a result of blood loss and remains a leading cause of death on the battlefield as well as worldwide.

Monitoring for the onset of circulatory shock in a wounded soldier on the battlefield is typically performed by measurement of arterial blood pressure (mean, systolic, diastolic), arterial oxygen saturation (oximetry), or simple auscultation of the pulse (rate and character).

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. Unfortunately, these signs are imprecise, subjective, and inconsistent.

Therefore, a definition based on the absence or presence of hypotension can be misleading since it does not represent the underlying problem of or the solution to hemorrhagic shock.

The resulting challenge is that shock is easily diagnosed in late stages when therapy is ineffective while early diagnosis is difficult because shock is first recognized by imprecise signs and subjective symptoms.

Condition	Intervention
Hemorrhagic Shock	Device: NIR/DOS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

provide information on physiologic status [ Time Frame: 5 to 60 seconds. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	35
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: NIR/DOS NIR/DOS measurements

Detailed Description:

The near-infrared diffuse optical spectroscopy (NIR-DOS) developed at the Beckman Laser Institute,UC Irvine, has ability to analyzes tissue regions deeper below the skin surface and reports on larger tissue volumes in muscle and brain.

The FDPM DOS instrument generates harmless amounts of low-level non-ionizing NIR ligh. The DOS probe will be applied to the selected sites with standard of care procedure. The measurement will be repeated several times to monitor the physiology. The monitoring will continue intermittently during the period of the experiment.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Army Medical Center, civilian and military

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581204

Locations


United States, California
	Beckman Laser Institute,University of California, Irvine
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Brooke Army Medical Center in Fort Sam Houston, Texas

Beckman Laser Institute Medical Clinic

Investigators


Principal Investigator:	Matthew Brenner, M.D	Beckman Laser Institute Medical Clinic

More Information

Responsible Party:	Beckman Laser Institute,University of California, Irvine ( Matthew Brenner,M.D )
Study ID Numbers:	FA 9550-04-1-0101, P41-RR01192;NIH-LAMMP
First Received:	December 19, 2007
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00581204
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

trauma situations

Lower Body Negative Pressure (LBNP)

Study placed in the following topic categories:

Shock

Wounds and Injuries

Hemorrhage

Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	University of California, Irvine Brooke Army Medical Center in Fort Sam Houston, Texas Beckman Laser Institute Medical Clinic
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581204