Feasibility and Performance Evaluation for INVSENSOR00024

Masimo

Status: Completed

Conditions: Evaluation of SpO2 Performance

Treatments: Device: RD SET Neo SpO2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03570255

HAMM0002

Details and patient eligibility

About

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Enrollment: 28 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than or equal to 1 month of age
• Weight <3kg
• Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion criteria

• 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, sever 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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28 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