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NCT01425151 Clinical Trial

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

Device Performance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01425151
Other study ID # Schulthess_Anä_2
Secondary ID
Status Completed
Phase N/A
First received August 26, 2011
Last updated September 20, 2011
Start date January 2010
Est. completion date September 2011

Study information
Verified date September 2011
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority Austria : Federal Ministry for Labour, Health, and Social Affairs
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 6 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• i-Gel
Oropharyngeal leak pressure Insertion success
• ProSeal
Oropharyngeal leak pressure Insertion success

Locations
Country Name City State
Austria Klinik für Anästhesie und Allgemeine Intensivmedizin Innsbruck
Switzerland Christian Keller Zürich

Sponsors (1)
Lead Sponsor Collaborator
Schulthess Klinik

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal leak pressure 10 Minutes Yes
Secondary Insertion success rate 1 Minute Yes