Trial Outcomes & Findings for SpO2 System Accuracy Testing With Different Sensors (NCT NCT01613222)

Last Updated: 2019-02-05

Results Overview

The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

60 minutes

Results posted on

2019-02-05

Participant Flow

The first subject was enrolled on June19, 2012 and the last subject was enrolled on February 15, 2013. The study was conducted at Clinimark, a human performance laboratory that tests physiological monitoring devices.

Participant milestones

Participant milestones
Measure	Pulse Oximetry Monitoring Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
Overall Study STARTED	63
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Pulse Oximetry Monitoring Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
Overall Study Physician Decision	1
Overall Study Unable to place arterial line	1
Overall Study Reused disposable sensors	10

Baseline Characteristics

SpO2 System Accuracy Testing With Different Sensors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulse Oximetry Monitoring n=51 Participants Pulse Oximetry Monitoring Single Arm
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.4 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants
SpO2	95.1 % oxygen STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: The data analyzed was SpO2 data pairs using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. Multiple data pairs were collected from each study participant, but not all sensors, patient monitors, co-oximeters and module configurations were used with each participant.

Outcome measures

Outcome measures
Measure	Pulse Oximetry Monitoring Using SpO@ Sensors n=2826 Number of Data Pairs Pulse oximetry measurement using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules.
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + B40 Patient Monitor	1.488 Accuracy Root Mean Square Interval -3.875 to 4.55
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + 3900 Oximeter	1.465 Accuracy Root Mean Square Interval -4.58 to 4.41
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + Carescape V100 & UTrusignal V2	1.651 Accuracy Root Mean Square Interval -3.5 to 7.1
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + Carescape V100	1.352 Accuracy Root Mean Square Interval -5.175 to 5.0
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + EPRESTN	2.179 Accuracy Root Mean Square Interval -7.005 to 8.42
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + M-NESTPR	1.813 Accuracy Root Mean Square Interval -7.7 to 3.65
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + M-OSAT	1.496 Accuracy Root Mean Square Interval -2.9 to 4.55
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + TruSat	1.612 Accuracy Root Mean Square Interval -4.865 to 7.71
Accuracy Root Mean Square (ARMS) TS-SA-D Sensor + TruSat	1.523 Accuracy Root Mean Square Interval -3.65 to 7.07
Accuracy Root Mean Square (ARMS) TS-AAW Sensor + TruffSat	1.286 Accuracy Root Mean Square Interval -3.275 to 4.55

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Conner

GEHealthcare

Phone: 414-477-8374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor cannot require changes to the PI's disclosure, with the exception of requesting the removal of sponsor's confidential information. The study results themselves are not considered confidential information. Sponsor cannot extend the embargo beyond 60 days unless the PI's disclosure contains patentable subject matter, in which an embargo beyond 60 days may be necessary to allow for the filing of a patent application
Publication restrictions are in place

Restriction type: OTHER