Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting

Masimo

Status

Completed

Conditions

Anemia

Healthy

Treatments

Device: Rad-67 Pulse oximeter & DCI Mini sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT04490863

SDBB0005

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.