Noninvasive Hemoglobin Testing, Prospective Blood Donors

Masimo

Status

Completed

Conditions

Anemia

Healthy

Treatments

Device: Rad-67 Pulse oximeter & DCI Mini sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT04450381

SDBB0004

Details and patient eligibility

About

The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.

Enrollment

131 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 and/or unable 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
Subjects 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
Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.