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Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069337
Collaborator
(none)
100
Enrollment
1
Location
11
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia
    Anticipated Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05069337
    Other Study ID Numbers:
    • 4-2021-1035
    First Posted:
    Oct 6, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 6, 2021