Convenience Sample Data Collection for INVSENSOR00045

Masimo Corporation7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Oxygen Saturation

Interventions

INVSENSOR00045DEVICE

Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.

Eligibility

Sex: ALLMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site 2

Orange, California, United States

Outcomes

Primary Outcomes

Form, Fit and Function of INVSENSOR00045.

To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).

Time frame: Up to 8 hours per subject.

Data from ClinicalTrials.gov

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