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

NCT06148623 | Completed Results FDA Device

• 1 other identifier: CIP-1088
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)

  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.

  1 hour

• Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)

  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.

  1 hour

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

Device: Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

Interventions

Philips FAST SpO2 with Masimo Pulse Oximetry Sensors DEVICE

Noninvasive pulse oximeter

Test Subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is 18 to 50 years of age.
• Subject weighs a minimum of 110 lbs.
• Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
• Blood Pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
• Hemoglobin value ≥ 11 g/dL.
• CO value ≤ 3.0% FCOHb.
• Subject can read and communicate in English and understands the study and the risks involved.

You may not qualify if:

• Subject is pregnant or breastfeeding.
• Subject has a BMI \> 35.
• Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
• Subject has open wounds, inflamed tattoos, or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation. \*
• Subject has finger deformities, nail deformities, nail polish, and/or gel/acrylic that can interfere with study device placement. \*
• Subject has known drug or alcohol abuse.
• Subject uses recreational drugs. \*
• Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
• Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
• Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.
• Subject has any chronic bleeding disorder (e.g., hemophilia).
• Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDs)).
• Subject has donated blood within the past 4 weeks.
• Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received clearance from their physician to participate.
• Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \*

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Dr. Ahmed Alghazi
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: November 13, 2023
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: April 2, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Locations

US (1)