Trial Outcomes & Findings for Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence (NCT NCT03134326)

Results Overview

Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=21 Participants All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Outcome measures

Outcome measures
Measure	Test Group n=21 Participants All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation R2-25 sensor	1.33 g/dL
Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation R1-25 sensor	1.41 g/dL

Adverse Events

Test Group

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60