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

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.

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Key information

Conditions

SpO2

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paradigm Clinical Research, Modesto, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

The acceptability of the quality of SpO2 signal obtained during non-invasive oxygen saturation monitoring using Philips FAST SpO2 technology with Masimo neonatal, infant, and pediatric sensors. Accuracy root mean square (ARMS) will be calculated.

Time frame: 45 minutes

Secondary outcomes

The acceptability of the fit of sensor by visual observation of the emitter and detector alignment.

Time frame: 45 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Frank

CONTACT

[email protected]

949-297-7000

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 31, 2025
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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