Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility



Status:Completed
Conditions:Healthy Studies, Anemia
Therapuetic Areas:Hematology, Other
Healthy:No
Age Range:Any
Updated:4/3/2019
Start Date:October 31, 2016
End Date:November 15, 2016

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Single-arm study to investigate the repeatability and reproducibility of SpHb measurements
from the Rad-67 and DCI Mini sensor.

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse
CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Inclusion Criteria:

- Age one month and older

- Weight greater than or equal to 3 kg

- The subject or the subject's legally authorized representative has given written
informed consent/assent to participate in the study

Exclusion Criteria:

- Decision-impaired adult and pediatric patients who are unable to give informed
consent/assent

- Decision-impaired adult on behalf of a pediatric patient who is unable to assent

- Subjects with skin abnormalities at the planned application sites that may interfere
with sensor application, per directions-for-use (DFU) or trans-illumination of the
site, such as burns, scar tissue, nail polish, acrylic nails, infections,
abnormalities, etc.

- Subjects deemed not suitable for the study at the discretion of the investigator

- Subjects unlikely to be able to refrain from excessive motion during data collection.
Excessive motion includes postural changes, making hand gestures, involuntary muscular
movements, etc.
We found this trial at
2
sites
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
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Irvine, California 92618
?
mi
from
Irvine, CA
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