Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Status: | Completed |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | August 1, 2018 |
End Date: | August 16, 2018 |
The primary objective of this clinical investigation is to evaluate the accuracy of using
Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to
hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to
hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Inclusion Criteria:
- 18 years of age or older
- Subject has given written informed consent to participate in the study
Exclusion Criteria:
- (*) Pregnant or positive human chorionic gonadotropin (hCG) test
- (*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent
thrombolysis
- (*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
- (*) Subjects who are currently taking anticoagulant medication
- (*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
- (*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin
breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
- (*) 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.
- (*) Subjects with elevated blood pressure, skin or wrist abnormalities that may
interfere with an arterial blood draw as determined by investigator or research
medical staff.
- (*) Subjects who intend on participating in heavy lifting, repetitive movement of
their wrist (including riding a motorcycle) or exercise (working out, riding a bike,
etc.), or any activity that will put additional stress on the wrist within 24 hours
following a study involving an arterial blood draw
- Subjects deemed not suitable for the study at the discretion of the investigator or
research medical staff
Note: (*) May be self-reported by subject
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