SpO2
Conditions
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.
Interventions
DEVICEMasimo 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
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 45 minutes |
Secondary
| Measure | Time frame |
|---|---|
| The acceptability of the fit of sensor by visual observation of the emitter and detector alignment. | 45 minutes |
Countries
United States
Contacts
CONTACTChelsea Frank
Outcome results
None listed