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Trial record 1 of 1 for:    aulisa
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Performance of Pulse Oximeter Sensors in Neonates

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ClinicalTrials.gov Identifier: NCT03870373
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Taiwan Aulisa Medical Devices Technologies, Inc.

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

Condition or disease Intervention/treatment
Cardiac Surgery 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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonatal patients undergoing complex cardiac surgical procedures.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870373


Locations
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United States, California
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
Sponsors and Collaborators
Taiwan Aulisa Medical Devices Technologies, Inc.
University of California, San Francisco
Investigators
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Principal Investigator: Hung G Nguyen, MD UCSF Medical Center at Mission Bay
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Responsible Party: Taiwan Aulisa Medical Devices Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03870373    
Other Study ID Numbers: 18-25904
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No