We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03355547
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

November 22, 2017
November 28, 2017
November 28, 2017
September 28, 2017
September 2018   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
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
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 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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pediatric patients between 6months and 6years old scheduled for elective general or urologic surgery at a single thetiary medical center.
Surgery
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.
  • no URI (upper respiratory tract infection) symptoms
    Patients without upper respiratory tract infection symptoms
    Intervention: 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
    Intervention: Other: questionnaire about the severity of their symptoms of upper respiratory tract infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
September 2018
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 6 Years   (Child)
No
Contact: Jeong-Rim LEE, MD, PhD 02-2227-3840 MANYA@yuhs.ac
Contact: Hye Mi Lee 82-11-9133-9906 ham9906@yuhs.ac
Korea, Republic of
 
 
NCT03355547
4-2017-0766
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
November 2017