HypoxemiaNCT04723017
Perioperative Hypoxemia in Pediatrics
An observational study of Hypoxemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Retrospective analysis cohort and Prospective validation cohort
- How many people
- 17,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2021to 31 Dec 2021
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients
Who may be able to join
- Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, 03080
Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr
Eun-Hee Kim, MD., 08201099335014, beloveun@gmail.com
About this study
Official title: Development and Validation of Perioperative Hypoxemia Using Clinical Big Data and Deep Learning Technique in Pediatric Patients
The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients
- Conditions
- Hypoxemia
- Being tested
- Retrospective analysis cohort, Prospective validation cohort
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis cohortOther
We analyze pre-existing data base and develop machine-learning-based system that predicts the risk of hypoxemia
Prospective validation cohortOther
We validate our model to predict the risk of hypoxemia to prospective cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxemia
pulse oximetry desaturation below 95%
Measured: from induction of anesthesia to end of operation, about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start21 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Cross-sectional
- Enrolment
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723017
- Sponsor's protocol ID
- 2011-208-1179
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Perioperative Hypoxemia Using Clinical Big Data and Deep Learning Technique in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04723017
- Acronym / sponsor ID
- 2011-208-1179
- Conditions
- Hypoxemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- 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.
The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients
Key inclusion criteria (1 listed)
- Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective analysis cohortWe analyze pre-existing data base and develop machine-learning-based system that predicts the risk of hypoxemia | Other | – |
| Prospective validation cohortWe validate our model to predict the risk of hypoxemia to prospective cohort | Other | – |
Primary outcome
hypoxemia
Time frame: from induction of anesthesia to end of operation, about 3 hours
pulse oximetry desaturation below 95%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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.
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 Hypoxemia, 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 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Soo Kim, professor (+82-2-2072-3664, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoxemia (time frame: from induction of anesthesia to end of operation, about 3 hours). 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 25 Jan 2021.