Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting

Not Applicable

Completed

• Conditions: Healthy; Anemia
• Interventions: Device: Rad-67 Pulse oximeter & DCI Mini sensor

• Registration Number: NCT04490863
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Primary Completion: 2020-08-20
• Study Completion: 2020-08-20
• Results First Submitted: 2021-07-06
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Results First Posted: 2021-08-31
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test subjects	Rad-67 Pulse oximeter & DCI Mini sensor	All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.

Primary Outcome Measures

Name	Time	Method
Coefficient of Variation of Rad-67	Approximately 90 minutes per subject	Coefficient of variation will be computed using Repeatability and Reproducibility variance.

Trial Locations

Locations (1)

Blood Bank - Site 1; 🇺🇸 San Diego, California, United States