Trial Outcomes & Findings for Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence (NCT NCT03157232)

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

18 participants

Primary outcome timeframe

1-5 hours per subject

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=18 Participants All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Age, Customized 26-65 years	18 participants n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United States	18 participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours per subject

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=18 Participants All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation Rainbow DCI	1.2 g/dL
Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation R1-25	1.2 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

Tala Harake

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place