Comparison of Physiological Variables During Blood Donation

Study Overview
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Brief Summary
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The investigators have developed a system based on a pulse oximeter, a tablet, and an algorithm running on the tablet that analyzes the pulse oximeter waveform. The algorithm that runs on this system should be able to accurately keep track of blood loss during blood donation. The investigators will compare the algorithm with the blood loss tracked by a device called a flow meter. The algorithm that runs on this system should be able to accurately keep track of stroke volume changes. The investigators will compare the algorithm with the stroke volume changes tracked by a device called a CCNexfin. The algorithm that runs on this system should work whether it's in place for the whole blood donation, or if it's placed after the blood donation has started. The investigators will use two pulse oximeters for the system on each hand and compare one that is used for the whole blood donation versus one that is not used for the whole blood donation.

Detailed Description
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Hypothesis: p-values for testing the hypothesis of no correlation against the alternative that there is a nonzero correlation for each subject will be calculated. The minimum average power correlation, alpha = 0.05, will be used. Correlation will be made (CRI trend during 550ml blood volume removal) using pre and post blood draw data. Specific Aims: These data will be submitted to the FDA with the following claims: The CRI algorithm Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of intravascular volume changes (hemorrhage) Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of stroke volume changes and The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does

Official Title
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Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation

Conditions
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Hemorrhage

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is planning on donating blood and is approved by Children's Hospital Colorado's Blood Donation Center Age 18-89 years Previously donated blood (lower likelihood of vasovagal response) Exclusion Criteria: Pregnant Incarcerated Limited access to or compromised monitoring sites for non-invasive finger sensors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood donors<br>Healthy adult volunteers donating blood | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intravascular volume | The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One. | Day One | 
| Change in Stroke volume | The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One. | Day One | 
| CRI trend | The CRI algorithm is intended to not require calibration, or being placed, during normal physiological conditions. This is measured Day One. | Day One |