Cyanotic Congenital Heart DiseasebluesensorNCT02712606
Accuracy of Pulse Oximeter With Hypoxemic Measurements
An observational study of Cyanotic Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cyanotic Congenital Heart Disease
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: tertiary care university children's hospital
Who may be able to join
- clinical diagnosis of cyanotic congenital heart disease
- weight 2.5kg to 30kg
- undergoing general anesthesia
- preoperative SpO2<97%
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study About Accuracy of Pulse Oximeter With Hypoxemic Measurements (Blue Sensor) in Children With Cyanotic Congenital Heart Disease
A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease
- Conditions
- Cyanotic Congenital Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From the start of anesthetic induction until discharge from hospital, assessed up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanotic Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712606
- Sponsor's protocol ID
- H-1602-060-740
- Acronym
- bluesensor
- Status last verified
- Apr 2018
- First submitted
- 9 Mar 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study About Accuracy of Pulse Oximeter With Hypoxemic Measurements (Blue Sensor) in Children With Cyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02712606
- Acronym / sponsor ID
- bluesensor / H-1602-060-740
- Conditions
- Cyanotic Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- tertiary care university children's hospital
Key inclusion criteria (4 listed)
- clinical diagnosis of cyanotic congenital heart disease
- weight 2.5kg to 30kg
- undergoing general anesthesia
- preoperative SpO2<97%
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyanotic Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of pulse oximetry using blue sensor (time frame: From the start of anesthetic induction until discharge from hospital, assessed up to 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.