Children Aged 6 Months to 10 Years Old Under General AnesthesiaNCT05069337
Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia
An observational study of Children Aged 6 Months to 10 Years Old Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Aged 6 Months to 10 Years Old Under General Anesthesia
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2021to Mar 2024
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children aged 6 months to 10 years old under general anesthesia
Who may be able to join
- children aged 6 months to 10 years old under general anesthesia
- ASA I-III
Who cannot join
- If the parents of the patient cannot communicate in Korean
- If mechanical ventilation is not planned (for example, A1 pulley)
- emergency operation
- a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures
- If lateral position was not available
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Hyo Jin Byon, 82-2-2228-2407, JINOBEN@YUHS.AC
About this study
For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it.
Read the detailed description
- routine general anesthesia is performed in the selected children.
- After mechanical ventilation, the degree of lung atelectasis is evaluated using transthoracic lung ultrasonography in the anterior, lateral, posterior regions of the upper and lower points of both lungs(a total of 12 regions).
- Atelectasis is checked by the presence of B-line and juxta pleural consolidation.
- Machine learning is used to educate the photos of 70 people and grading system, and process is checked whether it applies well to the photos of the remaining 30 people.
What is being measured
The primary outcome is the main question the study is designed to answer.
consolidation score
Sum of the consolidation scores at 12 lesions by the lung ultrasonography
Measured: After intubation and before the surgery start or after the surgery complete and before the extubation
Secondary outcomes (1)
B-line score
Sum of the B-line scores at 12 lesions by the lung ultrasonography
Measured: After intubation and before the surgery start or after the surgery complete and before the extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start24 Aug 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Aged 6 Months to 10 Years Old Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyo Jin Byon, Principal investigator, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069337
- Sponsor's protocol ID
- 4-2021-1035
- Status last verified
- May 2023
- First submitted
- 23 Sep 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT05069337
- Acronym / sponsor ID
- 4-2021-1035
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Oct 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.
For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it.
Detailed description
- routine general anesthesia is performed in the selected children.
- After mechanical ventilation, the degree of lung atelectasis is evaluated using transthoracic lung ultrasonography in the anterior, lateral, posterior regions of the upper and lower points of both lungs(a total of 12 regions).
- Atelectasis is checked by the presence of B-line and juxta pleural consolidation.
- Machine learning is used to educate the photos of 70 people and grading system, and process is checked whether it applies well to the photos of the remaining 30 people.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children aged 6 months to 10 years old under general anesthesia
Key inclusion criteria (2 listed)
- children aged 6 months to 10 years old under general anesthesia
- ASA I-III
Key exclusion criteria (5 listed)
- If the parents of the patient cannot communicate in Korean
- If mechanical ventilation is not planned (for example, A1 pulley)
- emergency operation
- a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures
- If lateral position was not available
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
consolidation score
Time frame: After intubation and before the surgery start or after the surgery complete and before the extubation
Sum of the consolidation scores at 12 lesions by the lung ultrasonography
1 secondary outcome
B-line score
Time frame: After intubation and before the surgery start or after the surgery complete and before the extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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.
Hyo Jin Byon principal investigator
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
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 Children Aged 6 Months to 10 Years Old Under General Anesthesia, run by Yonsei University 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 2 inclusion and 5 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 10 May 2023. 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 Hyo Jin Byon (82-2-2228-2407, JINOBEN@YUHS.AC), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consolidation score (time frame: After intubation and before the surgery start or after the surgery complete and before the extubation). 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 10 May 2023.