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

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ClinicalTrials.gov Identifier: NCT00854048
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Ulf Borg, Medtronic - MITG

Brief Summary:
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.

Condition or disease
Cardiopulmonary Bypass

Study Type : Observational
Actual Enrollment : 66 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources





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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.

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

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

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