Trial Outcomes & Findings for Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI) (NCT NCT03124823)

Results Overview

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement 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

11 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Test Subject All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subject n=11 Participants All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Age, Customized 24-43 years	11 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement 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	Test Subject n=598 data points All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Accuracy of Sensor by Arms Calculation	1.6 % of oxygen saturated hemoglobin

Adverse Events

Test Subject

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