Performance of Pulse Oximeter Sensors in Neonates

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Device: Pulse Oximeter

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Medical Center at Mission Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonatal patients undergoing complex cardiac surgical procedures.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test Subject; neonatal patients undergoing complex cardiac surgical procedures	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taiwan Aulisa Medical Devices Technologies, Inc.
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Hung G Nguyen, MD, UCSF Medical Center at Mission Bay

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 18-25904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No