Hemorrhage Clinical Trial
Official title:
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
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.
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
1. Is intended for use by clinicians and medically qualified personnel to noninvasively
display the trend of intravascular volume changes (hemorrhage)
2. Is intended for use by clinicians and medically qualified personnel to noninvasively
display the trend of stroke volume changes and
3. The CRI trend value is not relative to an initial CRI reading, instead it is an actual
CRI trend value that does
;
Observational Model: Case-Only, Time Perspective: Prospective
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