At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
U-TruSignal SpO2 Testing in Neonates
In Brief
A clinical study evaluating SpO2 Sensor application & blood draw for Pulse Oximetry. Completed, enrolled 117 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions \[50(k)s\]: Guidance for Industry and Food and Drug Administration Staff.)
Study Details
Timeline
Interventions
At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.