Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Children Aged 6 Months to 10 Years Old Under General Anesthesia

Detailed Description

1. routine general anesthesia is performed in the selected children.
2. 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).
3. Atelectasis is checked by the presence of B-line and juxta pleural consolidation.
4. 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Hyo Jin Byon; Phone Number: 82-2-2228-2407; Email: JINOBEN@YUHS.AC

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Contact: Hyo Jin Byon; Phone Number: 82-2-2228-2407; Email: JINOBEN@YUHS.AC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children aged 6 months to 10 years old under general anesthesia

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. If the parents of the patient cannot communicate in Korean
2. If mechanical ventilation is not planned (for example, A1 pulley)
3. emergency operation
4. a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures
5. If lateral position was not available

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Hyo Jin Byon, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 4-2021-1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No