Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations

NCT ID: NCT07223177

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2026-06-05

Brief Summary

The objective of this study is to verify the form, fit and function of the Philips FAST technology with Masimo neonatal, infant and pediatric sensors for SpO2 monitoring in the respective indicated populations. The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient populations that have a range of different skin pigmentations, simultaneously with an FDA cleared pulse oximeter as a comparator.

Conditions

SpO2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

All subjects are enrolled into this arm. All subjects will have blood oxygen measurements from:

• non-invasive Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm for blood oxygen measurements and
• Masimo RD SET sensors connected to FDA-cleared pulse oximeter

Group Type: EXPERIMENTAL

Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm

Intervention Type: DEVICE

Subjects may use multiple Masimo sensors (RD SET and/or LNCS). All subjects will have at least one Masimo sensor (RD SET or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

Interventions

Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm

Subjects may use multiple Masimo sensors (RD SET and/or LNCS). All subjects will have at least one Masimo sensor (RD SET or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor.
• Subject is less than 22 years of age (pediatric subject per US FDA definition).

Exclusion Criteria

• Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown).
• Confounders of pulse oximetry per sensor direction for use (DFU).
• Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied.
• Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
• Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it.
• Subject with known allergic reactions to adhesive tapes.
• Subject is not suitable for the investigation at the discretion of the clinical research team.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Paradigm Clinical Research

Modesto, California, United States

Site Status: NOT_YET_RECRUITING

Paradigm Clinical Research

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chelsea Frank

Role: CONTACT

clinicalresearchdept@masimo.com

949-297-7000

Facility Contacts

Chelsea Frank

Role: primary

949-297-7000

Chelsea Frank

Role: primary

949-297-7000

Other Identifiers

BERG0003

Identifier Type: -

Identifier Source: org_study_id