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NCT00854048 Clinical Trial

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

Cardiopulmonary Bypass Clinical Trial

Official title:
The Performance of Nellcor OxiMax N-560 and Masimo SET Radical Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00854048
Other study ID # M112
Secondary ID
Status Completed
Phase N/A
First received February 27, 2009
Last updated November 29, 2016
Start date December 2007
Est. completion date July 2008

Study information
Verified date November 2016
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Include pediatric patients with a baseline Sa02 < 90% and no contraindications to using an adhesive sensor.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Chidren's Hospital Chongqing University of Medical Sciences Chongqing

Sponsors (2)
Lead Sponsor Collaborator
Ulf Borg Medtronic - MITG

Country where clinical trial is conducted

China, 

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