Accuracy of Pulse Oximeter With Hypoxemic Measurements

Cyanotic Congenital Heart Disease Clinical Trial

— bluesensor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712606
• Other study ID #: H-1602-060-740
• Status: Completed
• First received: March 9, 2016
• Last updated: April 4, 2018
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of cyanotic congenital heart disease

• weight 2.5kg to 30kg

• undergoing general anesthesia

• preoperative SpO2<97%

Exclusion Criteria:

Related Conditions & MeSH terms

• Cyanotic Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of pulse oximetry using blue sensor	Each arterial blood gas sample and pulse oximeter oxygen saturation (SpO2) from blue sensor pulse oximetry are simultaneously obtained if the SpO2 is <97%.	From the start of anesthetic induction until discharge from hospital, assessed up to 1 week.