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 |
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.
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.
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