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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 0 Years and 21 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Paradigm Clinical Research
Modesto, California 95355
Contact:
Chelsea Frank
949-297-7000

Paradigm Clinical Research
San Diego, California 92108
Contact:
Chelsea Frank
949-297-7000

More Details

Status
Recruiting
Sponsor
Masimo Corporation

Study Contact

Chelsea Frank
949-297-7000
clinicalresearchdept@masimo.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.