Philips FAST SpO2 monitoring with Masimo neonatal, infant, and pediatric sensors

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

This project will test whether Philips FAST SpO2 technology works correctly with Masimo sensors to measure blood oxygen in newborns, infants, and children.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 0 Years to 21 Years
• Sex: All
• Sponsor: Masimo Corporation (Industry-sponsored)
• Locations: 2 sites (Modesto, California and 1 other locations)
• Trial ID: NCT07223177 on ClinicalTrials.gov

What this trial studies

This interventional convenience-sample study will connect Masimo neonatal, infant, and pediatric sensors (RD SET and/or LNCS) to a Philips monitor running the FAST SpO2 algorithm to verify form, fit, and function. Data will be collected from indicated patient populations (neonates through age 21) across a range of skin pigmentations. Measurements will be taken simultaneously with an FDA-cleared pulse oximeter as a comparator to compare readings. The aim is to confirm reliable sensor performance and proper sensor fit in the intended pediatric populations.

Who should consider this trial

Good fit: Ideal participants are neonates, infants, and pediatric patients under 22 years who fall within the indicated populations for the Philips FAST monitor and can tolerate standard sensor placement without exclusion criteria.

Not a fit: Patients with skin conditions at the sensor site, distinct localized pigmentary anomalies (e.g., vitiligo at the site), absence/deformity of limbs, severe edema, or who refuse removal of interfering nail polish/acrobatics are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could improve availability of compatible sensor-monitor pairings and help ensure accurate oxygen readings for babies and children using Masimo sensors with Philips monitors.

How similar studies have performed: Masimo sensors and pulse oximetry have been validated in prior studies, but the specific integration and verification of Masimo sensors with Philips' FAST algorithm is a focused compatibility check being performed here.

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.

Where this trial is running

Modesto, California and 1 other locations

• Paradigm Clinical Research — Modesto, California, United States (Recruiting)
• Paradigm Clinical Research — San Diego, California, United States (Recruiting)

Study contacts

• Study coordinator: Chelsea Frank

Conditions SpO2