Performance of Pulse Oximeter Sensors in Neonates

Taiwan Aulisa Medical Devices Technologies

Status: Completed

Conditions: Cardiac Surgery

Treatments: Device: Pulse Oximeter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03870373

18-25904

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Test Subject

Description:

neonatal patients undergoing complex cardiac surgical procedures

Treatment:

Device: Pulse Oximeter