A Study About Accuracy of Pulse Oximeter With Hypoxemic Measurements (Blue Sensor) in Children With Cyanotic Congenital Heart Disease

Seoul National University Hospital1 site in 1 country280 target enrollmentMarch 2016

ConditionsCyanotic Congenital Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cyanotic Congenital Heart Disease
Sponsor: Seoul National University Hospital
Enrollment: 280
Locations: 1
Primary Endpoint: accuracy of pulse oximetry using blue sensor
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

December 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•clinical diagnosis of cyanotic congenital heart disease
•weight 2.5kg to 30kg
•undergoing general anesthesia
•preoperative SpO2\<97%

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

accuracy of pulse oximetry using blue sensor

Time Frame: From the start of anesthetic induction until discharge from hospital, assessed up to 1 week.

Each arterial blood gas sample and pulse oximeter oxygen saturation (SpO2) from blue sensor pulse oximetry are simultaneously obtained if the SpO2 is \<97%.