Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

Completed · Not applicable

Conditions studied: Anemia

In brief

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).

Key facts

Study ID

NCT03610269

Run by

Masimo Corporation

People needed

143

Starts

2018-08-01

Expected to finish

2018-08-16

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older
• Subject has given written informed consent to participate in the study

You may not qualify if…

• (*) 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

Where it is running

• Torrance Clinical Research — Lomita, California, United States

Full record on ClinicalTrials.gov

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