NCT03870373

Performance of Pulse Oximeter Sensors in Neonates

Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Taiwan Aulisa Medical Devices Technologies, Inc. · Industry
• Sex: All
• Age: 0 Days – 1 Year
• Healthy volunteers: Not accepted

Summary

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Detailed description

Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DEVICE	Pulse Oximeter	Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-05-05
• Completion: 2019-05-10
• First posted: 2019-03-12
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study