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The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854048
First Posted: March 2, 2009
Last Update Posted: November 30, 2016
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.
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Ulf Borg, Medtronic - MITG
  Purpose
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.

Condition
Cardiopulmonary Bypass

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Performance of Nellcor OxiMax N-560 and Masimo SET Radical Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

Resource links provided by NLM:


Further study details as provided by Ulf Borg, Medtronic - MITG:

Enrollment: 66
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients after cardiopulmonary by-pass in the PICU.
Criteria

Inclusion Criteria:

  • Include pediatric patients with a baseline Sa02 < 90% and no contraindications to using an adhesive sensor.
  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): NCT00854048


Locations
China, Chongqing
Chidren's Hospital
Chongqing University of Medical Sciences, Chongqing, China
Sponsors and Collaborators
Ulf Borg
Medtronic - MITG
Investigators
Principal Investigator: Xu Feng, MD Children's Hospital Congqing Medical University
  More Information

Responsible Party: Ulf Borg, Director Clinical Science, Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00854048     History of Changes
Other Study ID Numbers: M112
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by Ulf Borg, Medtronic - MITG:
Pediatric
Oxygen Saturation
Cardiopulmonary bypass