Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03843489 |
Other study ID # |
PR2018-296 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 19, 2019 |
Est. completion date |
September 20, 2021 |
Study information
Verified date |
November 2021 |
Source |
Medline Industries |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.