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

Masimo

Status: Enrolling

Conditions: SpO2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223177

BERG0003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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