Trial Outcomes & Findings for Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI) (NCT NCT03124797)

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

18 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	RD DCI Sensor All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RD DCI Sensor n=18 Participants All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
Age, Customized 22-43 years	18 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 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	RD DCI Sensor n=492 data points All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
Accuracy of Sensor by Arms Calculation	1.9 % of oxygen saturated hemoglobin

Adverse Events

RD DCI Sensor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RD DCI Sensor n=18 participants at risk All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
Injury, poisoning and procedural complications Arterial line site sensitivity	5.6% 1/18

Additional Information

Tala Harake

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place