Feasibility and Performance Evaluation of INVSENSOR00024

Masimo Corporation12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Evaluation of SpO2 Performance

Interventions

RD SET Neo SpO2DEVICE

All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.

Eligibility

Sex: ALLMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Orange County

Orange, California, United States

Outcomes

Primary Outcomes

Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.

Time frame: up to 12 hours

Data from ClinicalTrials.gov

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