Noninvasive Hemoglobin Testing, Prospective Blood Donors

Noninvasive Hemoglobin Testing in Prospective Blood Donors

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Anemia
• Intervention / Treatment: Device: Rad-67 Pulse oximeter & DCI Mini sensor

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92102
      • Blood Bank - Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test subjects; All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.	Device: Rad-67 Pulse oximeter & DCI Mini sensor; Noninvasive pulse oximeter that measures hemoglobin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rad-67 Sensitivity	Sensitivity of the the Rad-67 will be determined for its use in a blood donation center	Up to one hour per subject
Rad-67 Specificity	Specificity of the the Rad-67 will be determined for its use in a blood donation center	Up to one hour per subject

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SDBB0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No