Trial Outcomes & Findings for Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children (NCT NCT03123354)

NCT ID: NCT03123354

Last Updated: 2018-06-13

Results Overview

The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: One visit; up to 4 hours
• Results posted on: 2018-06-13

Participant Flow

Participant milestones

Measure	O3 Regional Oximeter Sensors All subjects are enrolled in the test group and receive O3 regional oximeter sensors during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensors: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor
Overall Study STARTED	44
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	O3 Regional Oximeter Sensors All subjects are enrolled in the test group and receive O3 regional oximeter sensors during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensors: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor
Overall Study Physician Decision	6

Baseline Characteristics

Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

Baseline characteristics by cohort

Measure	O3 Regional Oximeter Sensors n=33 Participants All subjects are enrolled in the test group and receive the O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensor: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor.
Age, Customized 0-23 months	14 Participants n=5 Participants
Age, Customized 2-12 years	19 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	16 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic/Latino	11 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic	2 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: One visit; up to 4 hours

The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.

Outcome measures

Measure	O3 Regional Oximeter Sensors (Test Group) n=33 Participants All pediatric subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Accuracy of Sensor by Arms Calculation of Percent rSO2	5.0 %rSO2

Adverse Events

O3 Regional Oximeter 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

Measure	O3 Regional Oximeter Sensors n=44 participants at risk All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Skin and subcutaneous tissue disorders Mild rash, localized to sensor location	4.5% 2/44 • Number of events 2 • For each subject, adverse event data were collected up to 2 days after subject's single visit participation in the study. Subjects were observed during the procedure, as well as contacted via phone call up to 2 days after the procedure to gather adverse event information.

Additional Information

Vikram Ramakanth

Masimo Corporation

Phone: 1 (949) 297-7416

Email: clinicalresearchdept@masimo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60