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