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Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253772
First Posted: December 3, 2010
Last Update Posted: December 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
SterilMed, Inc.
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
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): NCT01253772


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

Responsible Party: Garrett Ahlborg, SterilMed, Inc.
ClinicalTrials.gov Identifier: NCT01253772     History of Changes
Other Study ID Numbers: STER01P
First Submitted: December 1, 2010
First Posted: December 3, 2010
Last Update Posted: December 3, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms