Performance of Pulse Oximeter Sensors in Neonates

Completed

• Conditions: Cardiac Surgery
• Interventions: Device: Pulse Oximeter

• Registration Number: NCT03870373
• Lead Sponsor: Taiwan Aulisa Medical Devices Technologies, Inc.

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Primary Completion: 2019-05-05
• Study Completion: 2019-05-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
• Consent signed by at least one legal guardian

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test Subject	Pulse Oximeter	neonatal patients undergoing complex cardiac surgical procedures

Primary Outcome Measures

Name	Time	Method
Performance of Pulse Oximeter Sensor in Neonates	Data are collected anywhere from the beginning of surgery until the completion of the procedure	Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)

Trial Locations

Locations (1)

UCSF Medical Center at Mission Bay; 🇺🇸 San Francisco, California, United States