Convenience Sample Data Collection for INVSENSOR00045

Masimo

Status: Terminated

Conditions: Oxygen Saturation

Treatments: Device: INVSENSOR00045

Study type: Interventional

Funder types: Industry

Identifiers

NCT04894669

CHOC0006

Details and patient eligibility

About

This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.

Enrollment: 7 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than or equal to 1 month of age
• Gestational age greater than 23 weeks
• Weight less than or equal to 5 kg
• Subjects with standard of care 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
• Subjects with axillary arterial lines
• Deformities of the limbs, absence of the 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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7 participants in 1 patient group

INVSENSOR00045

Experimental group

Description:

All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.

Treatment:

Device: INVSENSOR00045