Accuracy of Pulse Oximeter With Hypoxemic Measurements

Completed

• Conditions: Cyanotic Congenital Heart Disease

• Registration Number: NCT02712606
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Primary Completion: 2017-03
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy of pulse oximetry using blue sensor	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%.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of