CClinicalTrials.gg
CompletedNCT03355547Updated May 6, 2019

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

An observational study in Surgery, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
261
Ages
6 Months to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • undergoing laparoscopic surgery
  • pediatric patients with lower respiratory tract infection( pneumonia , bronchiolitis )
  • patients with bronchopulmonary dysplasia history
  • hemodynamic instability
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
261 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Otherquestionnaire 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.

05

What researchers measure

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.

    Time frame: 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

  1. 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.

    Time frame: 10 minutes after extubation at the post anesthesia care unit

  2. 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.

    Time frame: 30 minutes after extubation at the post anesthesia care unit

06

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
07

References and documents

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. PubMed 33727626 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03355547
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Sep 28, 2017
Primary completion
Feb 1, 2019
Completion
Feb 1, 2019
Last update
May 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion