Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm.
- Who it may be relevant to
- Registry conditions: SpO2. Basic parameters: 0 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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
Primary outcome measures
- 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 outcome measures (1)
- The acceptability of the fit of sensor by visual observation of the emitter and detector alignment. [Time frame: 45 minutes]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Paradigm Clinical Research — Modesto
- Paradigm Clinical Research — San Diego
Identifiers
NCT: NCT07223177 · BERG0003