NCT03383757

U-TruSignal SpO2 Testing in Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 29 Days
• Healthy volunteers: Not accepted

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.)

Detailed description

The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device. The study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor. After providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject. The duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded.

Conditions

• Pulse Oximetry

Interventions

Type	Name	Description
DEVICE	SpO2 Sensor application & blood draw	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.

Timeline

• Start date: 2017-09-14
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2017-12-26
• Last updated: 2020-12-04
• Results posted: 2020-12-04

Locations

2 sites across 2 countries: Finland, India