N/A
Completed N=143
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Source: ClinicalTrials.gov NCT03610269 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation — 0.93 g/dL
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation |
0.93 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03610269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.