Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

Recruiting

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

• Registration Number: NCT05069337
• Lead Sponsor: Yonsei University

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

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 Timeline

• Study Start: 2021-08-24
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
consolidation score	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of