N/A
N=26
Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting
Healthy · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT04490863 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Coefficient of Variation of Rad-67 — 4.50 Coefficient of Variation percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rad-67 Pulse oximeter & DCI Mini sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coefficient of Variation of Rad-67 |
4.50 | — |
Summary
The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04490863). 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.