Spot-Check Noninvasive Pulse CO-Oximeter Validation



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:4/3/2019
Start Date:April 11, 2016
End Date:May 19, 2016

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Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by
comparison to hemoglobin measurements from a laboratory analyzer.


Inclusion Criteria:

- Male or female

- Age: Greater than one month

- Weight: Greater than or equal to 3kg

- Any racial or ethnic group

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

- If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

Exclusion Criteria:

- 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
1
site
Irvine, California 92618
Phone: 949-297-7459
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mi
from
Irvine, CA
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