Biobank of Lung Ultrasonography in Children Undergoing Ge... | NCT05069337

Studies
Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

NCT05069337

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Children Aged 6 Months to 10 Years Old Under General Anesthesia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2021Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 2024Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
consolidation score	Sum of the consolidation scores at 12 lesions by the lung ultrasonography	After intubation and before the surgery start or after the surgery complete and before the extubation

Secondary Outcomes

Measure	Description	Time Frame
B-line score	Sum of the B-line scores at 12 lesions by the lung ultrasonography	After intubation and before the surgery start or after the surgery complete and before the extubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children aged 6 months to 10 years old under general anesthesia
ASA I-III

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

children aged 6 months to 10 years old under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyo Jin Byon	Contact	82-2-2228-2407		JINOBEN@YUHS.AC

Overall Officials

Name	Affiliation	Role
Hyo Jin Byon	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Yonsei University Health System	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided