NCT04196907CompletedNot Applicable
Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
Study Overview
Brief Summary
The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 years of age
- •Weight at least 110 pounds
- •Subjects with the intention of being screened for eligibility to donate blood
- •The subject has given written informed consent to participate in the study
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, infections, abnormalities, etc.
- •Subjects unwilling to remove nail polish or acrylic nails
- •Subjects with blood cancers such as leukemia
- •Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
- •Subjects with self-disclosed/known pregnancy at the time of enrollment
- •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.
Arms & Interventions
Test subjects
Experimental
All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.
Intervention: Rad-67 Pulse CO-Oximeter and DCI Mini sensor (Device)
Outcomes
Primary Outcomes
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
Time Frame: 1 hour
Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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