SpO2 Accuracy In Vivo Testing for Neonates & Infants

Medline Industries

Status: Withdrawn

Conditions: Pulse Oximetry

Treatments: Device: Reference CO-oximetry sensor; Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03843489

PR2018-296

Details and patient eligibility

About

The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and infants. The primary end goal is to provide supporting documentation for the SpO2 accuracy of these pulse oximetry systems. The secondary end goal is to provide data for evaluation of clinical impact of measured to calculated SaO2 and related issues.

Full description

FDA Guidance for pulse oximeters (March 4, 2013), section 4.1.2, In vivo testing for SpO2 accuracy for neonates, calls for the devices to be first tested in adults during hypoxia tests with arterial samples compared to measured oxygen saturation. This has been previously completed on the devices that will be tested in this protocol. In order to verify safe clinical performance in the neonate, the FDA then requires testing using neonatal arterial samples that are collected in the normal course of care; which is the primary purpose of this protocol. As a secondary purpose the data will be utilized to evaluate the impact of calculated oxygen saturation versus measured oxygen saturation and related issues.

Neonates/infants who will have an arterial line or sheath placed in the normal course of care will be included in this study. The pulse oximeter sensor must be placed on the Neonates/infant's foot or hand. Neonates who either have repaired PDA but are having the placement of the sensor on the foot (which will be arterial blood only) will be allowed as long as other inclusion/exclusion criteria are met.

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Neonates/Infants up to 28 days old
• Neonates/Infants less than 5kg.

And one of the following:

Without PDA With a PDA with R-L shunting that will be repaired before arterial samples are taken

Exclusion criteria

• Physical malformation of feet or toes or other sensor sites which would limit the ability to place the sensors for the study.
• Neonates/Infants older than 28 days old.
• Neonates/Infants outside the weight range for the sensor (Greater than 5kg.)
• Neonates/Infants with unrepaired PDA. with PDA with R-L shunting
• Subjects who are undergoing bilirubin light therapy while samples are being obtained.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

MEDLINE RENEWAL PULSE OXIMETRY SENSORS

Experimental group

Description:

Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance.

Treatment:

Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORS

Reference CO-oximetry sensor

Sham Comparator group

Description:

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Treatment:

Device: Reference CO-oximetry sensor