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Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

This study has been completed.
Sponsor:
Information provided by:
SterilMed, Inc.
ClinicalTrials.gov Identifier:
NCT01253772
First received: December 1, 2010
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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


Condition
Hypoxia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Further study details as provided by SterilMed, Inc.:

Primary Outcome Measures:
  • SpO2 Accuracy Verification Study (ARMS) of ≤ 3% [ Time Frame: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neonatal children undergoing complex cardiac surgical procedures.

Criteria

Inclusion Criteria:

  • Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
  • Understand and provide signed parental/guardian consent

Exclusion Criteria:

  • Failure to obtain parental consent
  • Patients shown to have an adverse reaction to medical tape/adhesive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253772

Sponsors and Collaborators
SterilMed, Inc.
Investigators
Principal Investigator: Greg Stratmann, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Garrett Ahlborg, SterilMed, Inc.
ClinicalTrials.gov Identifier: NCT01253772     History of Changes
Other Study ID Numbers: STER01P
Study First Received: December 1, 2010
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014