The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients

Not Applicable

Completed

• Conditions: Surgical Complications From General Anesthesia
• Interventions: Device: The cuff inflation by the maximum volume; Device: The cuff inflation by the resting volume

• Registration Number: NCT01435239
• Lead Sponsor: Yonsei University

Brief Summary

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• children (0-9 years of age)
• children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic

Exclusion Criteria

• patients with an abnormal airway
• patients with reactive airway disease
• patients with gastroesophageal reflux disease
• patients with chronic respiratory disease
• patients who has a history of an upper respiratory tract infection in the preceding 6-week period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maximum volume group	The cuff inflation by the maximum volume	-
resting volume group	The cuff inflation by the resting volume	-

Primary Outcome Measures

Name	Time	Method
The intra-cuff pressure	approximately 5 to 10 minutes after insertion of LMA.	1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
The leak volume	approximately 5 to 10 minutes after insertion of LMA.	1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of