Trial Outcomes & Findings for Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions (NCT NCT03124784)

Last Updated: 2018-03-23

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 error (Arms) 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

Target enrollment

27 participants

Primary outcome timeframe

1-5 hours

Results posted on

2018-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	RD Disposable Sensors All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Overall Study STARTED	27
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RD Disposable Sensors All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Overall Study Adverse Event	1
Overall Study Computer/Equip Malfunction	1

Baseline Characteristics

Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RD Disposable Sensors n=25 Participants All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors RD Disposable Sensors: Noninvasive pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race/Ethnicity, Customized African American	7 Participants n=93 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=93 Participants
Region of Enrollment United States	25 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Population: 2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction.

Outcome measures

Outcome measures
Measure	RD Disposable Sensors n=25 Participants All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
SpO2 ARMS of Sensor Under Motion Conditions	1.31 % of oxygen saturated hemoglobin

Adverse Events

RD Disposable Sensors

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RD Disposable Sensors n=27 participants at risk All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Injury, poisoning and procedural complications Sensitivity at site of arterial line placement	3.7% 1/27 • Number of events 1 • Adverse event data was collected over the course of the study (within 1 month).
General disorders Irregular heart rate	3.7% 1/27 • Number of events 1 • Adverse event data was collected over the course of the study (within 1 month).

Additional Information

Tala Harake

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place