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Trial record 46 of 619 for:    oximeter

Accuracy of Pulse Oximeter With Hypoxemic Measurements (bluesensor)

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ClinicalTrials.gov Identifier: NCT02712606
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, 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

Condition or disease
Cyanotic Congenital Heart Disease

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Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study About Accuracy of Pulse Oximeter With Hypoxemic Measurements (Blue Sensor) in Children With Cyanotic Congenital Heart Disease
Study Start Date : March 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary care university children's hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712606


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Jin-Tae Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02712606     History of Changes
Other Study ID Numbers: H-1602-060-740
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities