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

NCT03355547 | Completed

• 1 other identifier: 4-2017-0766
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Occurrence of respiratory adverse effects after the operation

  10 minutes after extubation at the post anesthesia care unit

• Occurrence of respiratory adverse effects after the operation

  30 minutes after extubation at the post anesthesia care unit

Study Arms (2)

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

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

Interventions

questionnaire about the severity of their symptoms of upper respiratory tract infection OTHER

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; no URI (upper respiratory tract infection) symptoms

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33727626 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: September 28, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)