NCT03843489

SpO2 Accuracy In Vivo Testing for Neonates & Infants

SpO2 Accuracy In Vivo Testing for Neonates & Infants - Convenience Arterial Samples Compared to CO-Oximetry

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Pulse Oximetry

Interventions

Type	Name	Description
DEVICE	MEDLINE RENEWAL PULSE OXIMETRY SENSORS	An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.
DEVICE	Reference CO-oximetry sensor	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.

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2019-02-18
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study