NCT02712606

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 9, 2016

Last Update Submit

April 4, 2018

Conditions

Cyanotic Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

tertiary care university children's hospital

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 18, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

KR(1)