Rad-67 Repeatability and Reproducibility

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04196907
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Days): 1
• Patients Per Site Per Month: 608.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting
• Actual Study Start Date: Nov 19, 2019
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. [1 hour]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego Blood Bank	San Diego	California	United States	92102

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 14, 2019

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT04196907
• Other Study ID Numbers: SDBB0002
• First Posted: Dec 12, 2019
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

Study Results

Participant Flow

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin. Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin. Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 95%
>=65 years	1 5%
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 10%
Native Hawaiian or Other Pacific Islander	1 5%
Black or African American	0 0%
White	8 40%
More Than One Race	0 0%
Unknown or Not Reported	0 0%
Hispanic	9 45%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin. Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
Measure Participants	20
Number [ratio of variance]	10

Adverse Events

Time Frame	1 hour
Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin. Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
All Cause Mortality
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.