Feasibility and Performance Evaluation of INVSENSOR00024

Completed · Not applicable

Conditions studied: Evaluation of SpO2 Performance

In brief

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.

Key facts

Study ID

NCT03831282

Run by

Masimo Corporation

People needed

12

Starts

2019-02-08

Expected to finish

2019-05-28

Last updated by the study team

2020-02-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Orange County — Orange, California, United States

Full record on ClinicalTrials.gov

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