We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425151
First Posted: August 29, 2011
Last Update Posted: September 22, 2011
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.
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik
  Purpose
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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by ChristianKeller, Schulthess Klinik:

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

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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01425151


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

Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01425151     History of Changes
Other Study ID Numbers: Schulthess_Anä_2
First Submitted: August 26, 2011
First Posted: August 29, 2011
Last Update Posted: September 22, 2011
Last Verified: September 2011