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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

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ClinicalTrials.gov Identifier: NCT03355547
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single thetiary 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 indeced 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 atelecatisis 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.

Condition or disease Intervention/treatment
Surgery Other: questionnaire about the severity of their symptoms of upper respiratory tract infection

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. The degree of atelectasis due to general anesthesia using lung ultrasound [ 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. ]
    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 atelecatisis 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.


Secondary Outcome Measures :
  1. Occurrence of respiratory adverse effects after the operation [ Time Frame: 10 minutes after extubation at the post anesthesia care unit ]
    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 larnyngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratiory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.

  2. Occurrence of respiratory adverse effects after the operation [ Time Frame: 30 minutes after extubation at the post anesthesia care unit ]
    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 larnyngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratiory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

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(penumonia, brionchiolitis)
  • patients with bronchopulmonary dysplasia history
  • hemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355547


Contacts
Contact: Jeong-Rim LEE, MD, PhD 02-2227-3840 MANYA@yuhs.ac
Contact: Hye Mi Lee 82-11-9133-9906 ham9906@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong-Rim LEE, MD, PhD    02-2227-3840    MANYA@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03355547     History of Changes
Other Study ID Numbers: 4-2017-0766
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Tract Infections
Pulmonary Atelectasis
Infection
Respiratory Tract Diseases
Lung Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs