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Completed

NCT Number: NCT03870373

Performance of Pulse Oximeter Sensors in Neonates

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

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Key information

Conditions

Cardiac Surgery

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Oximeter

Device

Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.

Primary outcomes

  1. Performance of Pulse Oximeter Sensor in Neonates

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taiwan Aulisa Medical Devices Technologies, Inc.

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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