Trial Outcomes & Findings for Rad-67 Repeatability and Reproducibility (NCT NCT04196907)

NCT ID: NCT04196907

Last Updated: 2021-09-29

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2021-09-29

Participant Flow

Participant milestones

Measure	Test Subjects 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 Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rad-67 Repeatability and Reproducibility

Baseline characteristics by cohort

Measure	Test Subjects n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants
Race/Ethnicity, Customized More Than One Race	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Test Subjects n=20 Participants 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.
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.	10 ratio of variance

Adverse Events

Test Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vikram Ramakanth

Masimo Corporation

Phone: 949-297-7000

Email: clinicalresearchdept@masimo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60