Comparison of Physiological Variables During Blood Donation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02029807

Enrollment

Registered

2014-01-08

Start date

2014-01-31

Completion date

2016-06-30

Last updated

2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results