Feasibility and Performance Evaluation of INVSENSOR00024

Masimo

Status: Completed

Conditions: Evaluation of SpO2 Performance

Treatments: Device: RD SET Neo SpO2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03831282

CHOC0004

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

RD SET Neo SpO2

Experimental group

Description:

All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.

Treatment:

Device: RD SET Neo SpO2