Verification of Pulse Oximetry in Neonatal Population

Completed

Conditions studied: Respiratory Distress Syndrome

In brief

The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.

Key facts

Study ID

NCT00751439

Run by

Children's Hospitals and Clinics of Minnesota

People needed

25

Starts

2008-06-01

Expected to finish

2009-09-01

Last updated by the study team

2010-06-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age: 25 weeks to full term
• Weight range: No minimum or maximum range
• Age: up to 1 month (30 DAYS)
• Gender: Both
• ABGs as part of their medical care, to be analyzed by co-oximeter
• Consent signed by at least one legal guardian

You may not qualify if…

• Presence of any skin irritation or breakdown on the foot
• Foot impediments which would preclude proper placement of the sensor
• Clinical condition precluding the use of adhesive materials
• Cessation of ABGs during study enrollment

Where it is running

• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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