N/A
N=12
Feasibility and Performance Evaluation of INVSENSOR00024
Evaluation of SpO2 Performance
Bottom Line
View on ClinicalTrials.gov: NCT03831282 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation — 3.5 percent of oxygen saturated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RD SET Neo SpO2 (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation |
3.5 | — |
Summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
Eligibility Criteria
Inclusion Criteria
- Less than or equal to 1 month (28 days) of age
- Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent.
- Subjects admitted with standard of care (SOC) arterial blood sampling line already in place
Exclusion Criteria
- Subjects with both significant abnormal aortic arch and radial line in place
- Subjects with suspected or diagnosed critical congenital heart disease (CCHD)
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Deformities of limbs, absence of feet, severe edema, and other at the discretion of the Principal Investigator
Data sourced from ClinicalTrials.gov (NCT03831282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.