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

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

March 13, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00581204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Hemorrhagic Shock

Intervention ^ICMJE

Device: NIR/DOS

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00581204

Responsible Party

Matthew Brenner,M.D, Beckman Laser Institute,University of California, Irvine

Study ID Numbers ^ICMJE

LAMMP DOS RR-01192-29

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Brooke Army Medical Center
Beckman Laser Institute University of California Irvine

Investigators ^ICMJE

Principal Investigator:

Matthew Brenner, M.D

Beckman Laser Institute University of California Irvine

Information Provided By

University of California, Irvine

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP