Status:
COMPLETED
Feasibility and Performance Evaluation of INVSENSOR00024
Lead Sponsor:
Masimo Corporation
Conditions:
Evaluation of SpO2 Performance
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief 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 samplin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03831282
Start Date
February 8 2019
End Date
May 28 2019
Last Update
February 25 2020
Active Locations (1)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868