Trial Outcomes & Findings for Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor (NCT NCT03134313)

Results Overview

Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter 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 the 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

25 participants

Primary outcome timeframe

1-5 hours per subject

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	R1-25 Sensor All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R1-25 Sensor n=25 Participants All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours per subject

Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter 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 the 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	R1-25 Sensor n=25 Participants All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Accuracy of SpHb on R1-25 by Arms Calculation	1.0 g/dL

Adverse Events

R1-25 Sensor

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