SpO2 Accuracy In Vivo Testing for Neonates & Infants

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pulse Oximetry

Clinical Trial Details

NCT number	NCT03843489
Study type	Interventional
Source	Medline Industries
Contact
Status	Terminated
Phase	N/A
Start date	March 19, 2019
Completion date	September 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02846974` - Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
Completed	`NCT03383757` - U-TruSignal SpO2 Testing in Neonates	N/A
Recruiting	`NCT04233827` - Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Completed	`NCT02987985` - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy	Phase 3
Completed	`NCT05185427` - Pulse Oximetry and Skin Pigmentation - Peds
Completed	`NCT01472133` - Validation of Respiration Rate Algorithms	N/A
Completed	`NCT01613222` - SpO2 System Accuracy Testing With Different Sensors	N/A
Enrolling by invitation	`NCT05681637` - SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation	N/A
Completed	`NCT05657665` - Skin Tone Measurement Method Investigation for Pulse Oximetry
Completed	`NCT06454318` - Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
Enrolling by invitation	`NCT05657288` - SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia	N/A
Not yet recruiting	`NCT05994417` - Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
Recruiting	`NCT05554510` - Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
Enrolling by invitation	`NCT06298422` - Oxygen Saturations Across Tones of Skin
Recruiting	`NCT06063148` - Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation	N/A