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Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume

NCT01935427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2015-03-06

No results posted yet for this study

Summary

This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI system.

Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating, nausea, or dizziness) to validate the following hypotheses:

The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does not require calibration or being placed during normal physiological conditions.

Conditions

Sponsors & Collaborators

  • Flashback Technologies

    lead INDUSTRY

Principal Investigators

  • Victor A Convertino, Ph.D. · US Army Institute of Surgical Research

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01935427 on ClinicalTrials.gov