Trial Outcomes & Findings for Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation (NCT NCT06148623)

Results Overview

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

1 hour

Results posted on

2026-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Overall Study STARTED	70
Overall Study Participants Who Received RD SET® Adt	28
Overall Study Participants Who Received RD SET® Adt CS	28
Overall Study Participants Who Received RD SET® YI	28
Overall Study Participants Who Received RD SET® DBI	28
Overall Study Participants Who Received LNCS® Adtx	36
Overall Study Participants Who Received RD SET® TC-I	30
Overall Study Participants Who Received RD SET® DCI	36
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors n=67 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized White	18 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	8 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Mutiracial	2 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® Adt sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=25 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)	1.84 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® Adt CS sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=25 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)	1.9 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 24 participants were included in RD SET® YI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=24 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)	2.01 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® DBI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=25 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)	1.99 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in LNCS® Adtx sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=28 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)	2.84 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in RD SET® TC-I sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=28 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)	3.12 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1 hour

Population: The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in RD SET® DCI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study.

The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.

Outcome measures

Outcome measures
Measure	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt) n=28 Participants All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)	3.85 % of oxygen saturated hemoglobin

Adverse Events

Test Subject

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Subject n=70 participants at risk All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter
Injury, poisoning and procedural complications Lightheadedness	8.6% 6/70 • 1 hour
Gastrointestinal disorders Nausea	5.7% 4/70 • 1 hour
Cardiac disorders Tachycardia	1.4% 1/70 • 1 hour
Nervous system disorders Numbness	1.4% 1/70 • 1 hour
Vascular disorders Hypotension	1.4% 1/70 • 1 hour
Investigations Abnormal Laboratory Finding	7.1% 5/70 • 1 hour

Additional Information

Dr. Ahmed Alghazi

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place