Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children

LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of LMA insertion. When the investigators evaluate the LMA position, the investigators can use fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will bring high risk of aspiration. Recent studies reported the LMA position after general anesthesia induction not after operation. Therefore, the investigators will observe the LMA position three times; after general anesthesia induction, after caudal block, and after operation as well as the difference regarding to spontaneous and controlled ventilation.

Study Overview

• Status: Completed
• Conditions: Pediatric Urologic Surgery

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients who are planed to get urologic surgery under general anesthesia using LMA

Description

Inclusion Criteria:

1. ASA physical status 1 or 2,
2. pediatric patients from 1month to 7 years old
3. under general anesthesia using LMA
4. getting informed consent from the guardian

Exclusion Criteria:

1. difficult airway
2. airway diseases ; URI, asthma, pneumonia
3. not getting informed consent from the guardian

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
spontaneous group; maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2
controlled group; controlled ventilation(tidal volume 8ml/kg, ET CO2 35~40mmHg) during the operation, recording peak airway pressure, SpO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sucess rate of LMA insertion	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FOB(fiberoptic bronchoscope) grading of LMA position	Grade 1: only the larynx visible, Grade 2: larynz and epiglottis visible, Grade 3: epiglottis was impinging on the LMA grille, Grade 4: epiglottis was downfolded and the larynx could not be seen)	1 hour

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2015
• Primary Completion (Actual): April 3, 2015
• Study Completion (Actual): April 3, 2015

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: fiberoptic, LMA, caudal block
• Other Study ID Numbers: 4-2013-0550