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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425151
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : September 22, 2011
Information provided by (Responsible Party):
ChristianKeller, 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.

Condition or disease Intervention/treatment Phase
Device Success Rate Device Performance Device: i-Gel Device: ProSeal Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: i-Gel Device: i-Gel
Oropharyngeal leak pressure Insertion success

Experimental: ProSeal Device: ProSeal
Oropharyngeal leak pressure Insertion success

Primary Outcome Measures :
  1. Oropharyngeal leak pressure [ Time Frame: 10 Minutes ]

Secondary Outcome Measures :
  1. Insertion success rate [ Time Frame: 1 Minute ]

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Ages Eligible for Study:   18 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik Identifier: NCT01425151     History of Changes
Other Study ID Numbers: Schulthess_Anä_2
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011