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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355547
• Other study ID #: 4-2017-0766
• Status: Completed
• Start date: September 28, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Atelectasis
• Respiratory Tract Infections
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-de?ned 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	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
Secondary	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