Neonatal Pulse Oximetry Sensor Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates

Conditions
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Premature Birth

Intervention / Treatment
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* Device: Pulse oximeter sensors


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pulse oximeter sensor readings<br>Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate. | Device: Pulse oximeter sensors<br>* Pulse oximeter reading will be compared to CO-oximeter reading.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse oximeter and co-oximeter readings | Pulse oximeter and co-oximeter reading pair used to determine the accuracy of each pulse oximeter. This will be achieved by evaluating root mean square (ARMS), bias, and precision of the readings. | Approximately 15 episodic minutes at the time of the blood draw |