Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis

Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single tertiary medical center. Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The researcher will get the symptom score of the upper respiratory tract infection in the questionnaire. The degree of anesthesia induced atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after endotracheal intubation and at the end of the operation dividing the patient's thorax into 12 regions. The investigator grades the degree of atelectasis at each region form 0 to 3 points. After the end of the operation, check whether the respiratory adverse effects occurred during emergence and recovery at the post anesthesia care unit.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: questionnaire about the severity of their symptoms of upper respiratory tract infection

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients between 6months and 6years old scheduled for elective general or urologic surgery at a single thetiary medical center.

Description

Inclusion Criteria:

• Age: Pediatric patients older than 6 months and younger than 6 years
• scheduled for elective pediatric general or urology surgery.

Exclusion Criteria:

• undergoing laparoscopic surgery
• pediatric patients with lower respiratory tract infection( pneumonia , bronchiolitis )
• patients with bronchopulmonary dysplasia history
• hemodynamic instability

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no URI (upper respiratory tract infection) symptoms; Patients without upper respiratory tract infection symptoms	Other: questionnaire about the severity of their symptoms of upper respiratory tract infection; Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients.
URI (upper respiratory tract infection) symptoms; Patients with upper respiratory tract infection symptoms	Other: questionnaire about the severity of their symptoms of upper respiratory tract infection; Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of atelectasis due to general anesthesia using lung ultrasound	Anesthesia induced atelectasis is diagnosed when the ultrasound findings as B-line (appears hyperechoic lines perpendicular to the pleura) and consolidation(loss of pleural line and hypoechoic area) are identified. The chest is divided into 12 regions: three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines (above the diaphragm, and 1cm above the nipples) in each hemithorax. The investigator grades the degree of atelectasis at each region form 0 to 3 points. The degree of juxtapleural consolidation was graded: (a0) no consolidation; (a1) minimal juxtapleural consolidation; (a2) small-sized consolidation(<50%); and (a3) large-sized consolidation(>50%). The degree of B-lines was divided into four grades: (b0) fewer than three isolated B-lines; (b1) multiple well-defined B-lines; (b2) multiple coalescent B-lines; and (b3) white lung.	The investigator will measure the degree of atelectasis using lung ultrasound at 2 minutes after endotracheal intubation and at 5minutes the end of the operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of respiratory adverse effects after the operation	After the end of the operation, check whether the respiratory adverse effects occurred when the patient is extubated and 10, 30 minutes after extubation at the post anesthesia care unit. Respiratory adverse effects are bronchospasm and laryngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.	10 minutes after extubation at the post anesthesia care unit
Occurrence of respiratory adverse effects after the operation	After the end of the operation, check whether the respiratory adverse effects occurred when the patient is extubated and 10, 30 minutes after extubation at the post anesthesia care unit. Respiratory adverse effects are bronchospasm and laryngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.	30 minutes after extubation at the post anesthesia care unit

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Lee HM, Byon HJ, Kim N, Gleich SJ, Flick RP, Lee JR. Effect of upper respiratory infection on anaesthesia induced atelectasis in paediatric patients. Sci Rep. 2021 Mar 16;11(1):5981. doi: 10.1038/s41598-021-85378-0.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Respiratory Tract Infections
• Other Study ID Numbers: 4-2017-0766

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