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

NCT ID: NCT02220075

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-04
• Study Completion Date: 2015-04-03

Brief Summary

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.

Conditions

Pediatric Urologic Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

spontaneous group

maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2

No interventions assigned to this group

controlled group

controlled ventilation(tidal volume 8ml/kg, ET CO2 35\~40mmHg) during the operation, recording peak airway pressure, SpO2

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2013-0550

Identifier Type: -

Identifier Source: org_study_id