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

Not Applicable

Completed

• Conditions: Device Success Rate; Device Performance
• Interventions: Device: i-Gel; Device: ProSeal

• Registration Number: NCT01425151
• Lead Sponsor: Schulthess Klinik

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
i-Gel	i-Gel	-
ProSeal	ProSeal	-

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	10 Minutes

Secondary Outcome Measures

Name	Time	Method
Insertion success rate	1 Minute

Trial Locations

Locations (2)

Klinik für Anästhesie und Allgemeine Intensivmedizin; 🇦🇹 Innsbruck, Austria

Christian Keller; 🇨🇭 Zürich, Switzerland