The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

Schulthess Klinik60 enrolled

Overview

In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Device Success Rate Device Performance

Interventions

i-GelDEVICE

Oropharyngeal leak pressure Insertion success

ProSealDEVICE

Oropharyngeal leak pressure Insertion success

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA I and II * Age 1.5-6 years Exclusion Criteria: * known or predicted difficult airway * body mass index \> 35 kg m-2 * risk of aspiration

Locations (2)

Klinik für Anästhesie und Allgemeine Intensivmedizin

Innsbruck, Austria

Christian Keller

Zurich, Switzerland

Outcomes

Primary Outcomes

Oropharyngeal leak pressure

Time frame: 10 Minutes

Secondary Outcomes

Insertion success rate

Time frame: 1 Minute

Data from ClinicalTrials.gov

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