Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume
1 other identifier
observational
20
0 countries
N/A
Brief Summary
The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index (CRI) numeric and graphical trend readings to intravascular volume changes as compared to graded blood loss (removal of 20% of estimated total blood volume in \~333 mL aliquots) and to stroke volume as measured by the Nexfin monitor during the same graded blood removal period. Enrollment includes both men and women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 30, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedDecember 2, 2016
December 1, 2016
1 month
November 30, 2016
December 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of CipherOx trend to blood removal for trending intravascular volume
comparison of CipherOx reading trend before removal of blood, post 330mL, 660mL and 1,000mL blood removal for trending intravascular volume change
1 hour
Interventions
Blood removal and reintroduction as measured by the plethysmograph of a pulse oximeter
Eligibility Criteria
Twenty healthy volunteers between the ages of 18 and 55, men and women, American Society of Anesthesiology "class 1" health status.
You may qualify if:
- Ages 18-55.
- Physical status: Healthy ASA Class 1.
- Male or female.
- Screening hemoglobin \> 13.5 g/dl and hematocrit \> 39% for males
- Screening hemoglobin \> 12 g/dl and hematocrit \> 35% for females
- BMI \<30
- Ability to provide written informed consent.
- Willing and able to comply with study procedures
You may not qualify if:
- Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
- Subjects with history of cardiovascular disease, hypertension, diabetes or any other diseases/conditions that might negatively influence their ability to tolerate moderate but temporary blood loss.
- Obese subjects (BMI\>30)
- Smoker.
- Subjects on drugs of any type (except oral contraceptives).
- Female subjects that are actively trying to get pregnant or are pregnant.
- Subjects taking blood thinners or medications with antiplatelet factors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flashback Technologieslead
- Duke Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2016
First Posted
December 2, 2016
Study Start
March 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 2, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share