Neonatal Pulse Oximetry Sensor Study

Medline Industries23 enrolled

Overview

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Premature Birth

Interventions

Pulse oximeter sensorsDEVICE

Pulse oximeter reading will be compared to CO-oximeter reading.

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are postnatal 28 days or younger (neonates) * Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC * Subjects who weigh less than 5 Kg (weight range for thesensors) Exclusion Criteria: * Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement * Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study * Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study * Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)

Locations (2)

Children's Hospital Los Angeles

Los Angeles, California, United States

Eastern Carolina University

Greenville, North Carolina, United States

Outcomes

Primary Outcomes

Bland-Altman Analysis for Nellcor Pulse Oximeter

BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.

Time frame: 15 episodic minutes

Data from ClinicalTrials.gov

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