Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

N/ACompletedNCT01320163

Seoul National University Hospital108 enrolled

Overview

This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Conditions

Endotracheal Intubation

Interventions

i-gel airway (Intersurgical Ltd., Wokingham, England)DEVICE

supra-glottic airway device

Laryngeal Mask AirwayDEVICE

supra-glottic airway device

Eligibility

Sex: ALLMin age: 1 YearMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary Exclusion Criteria: * Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status * upper airway abnormality

Locations (1)

Seoul national university hospital

Seoul, South Korea

Outcomes

Primary Outcomes

airway leak pressure

Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Time frame: within 5 min of insertion of each device

Data from ClinicalTrials.gov

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