Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490863
• Other study ID #: SDBB0005
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: August 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Healthy

Intervention

Device:
• Rad-67 Pulse oximeter & DCI Mini sensor
Noninvasive pulse oximeter that measures hemoglobin

Locations

Country	Name	City	State
United States	Blood Bank - Site 1	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of Variation of Rad-67	Coefficient of variation will be computed using Repeatability and Reproducibility variance.	Approximately 90 minutes per subject