Rad-67 Repeatability and Reproducibility

Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting

The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor

• Study Type: Interventional
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92102
      • San Diego Blood Bank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 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.

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 and DCI Mini sensor for measurement of hemoglobin.	Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor; Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.	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.	1 hour

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SDBB0002