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

This study has been completed.
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik Identifier:
First received: August 26, 2011
Last updated: September 20, 2011
Last verified: September 2011
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.

Condition Intervention
Device Success Rate
Device Performance
Device: i-Gel
Device: ProSeal

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

Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • Oropharyngeal leak pressure [ Time Frame: 10 Minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Insertion success rate [ Time Frame: 1 Minute ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: i-Gel Device: i-Gel
Oropharyngeal leak pressure Insertion success
Experimental: ProSeal Device: ProSeal
Oropharyngeal leak pressure Insertion success


Ages Eligible for Study:   18 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01425151

Klinik für Anästhesie und Allgemeine Intensivmedizin
Innsbruck, Austria, 6020
Christian Keller
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Principal Investigator: Christian Keller, MD, M.Sc. Schulthess Klinik
  More Information

Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik Identifier: NCT01425151     History of Changes
Other Study ID Numbers: Schulthess_Anä_2 
Study First Received: August 26, 2011
Last Updated: September 20, 2011
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs processed this record on May 26, 2016