SpO2 Accuracy In Vivo Testing for Neonates & Infants

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 19, 2019

Primary Completion Date

September 20, 2021

Study Completion Date

September 20, 2021

Conditions
Pulse Oximetry
Interventions
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.

Trial Locations (1)

80045

Children's Hospital Colorado, Aurora

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Clinimark, LLC

OTHER

lead

Medline Industries

INDUSTRY