Performance of Pulse Oximeter Sensors in Neonates

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870373
• Other study ID #: 18-25904
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: March 2021
• Source: Taiwan Aulisa Medical Devices Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 10, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Taiwan Aulisa Medical Devices Technologies, Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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