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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01425151
First received: August 26, 2011
Last updated: September 20, 2011
Last verified: September 2011
  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
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

  Eligibility

Ages Eligible for Study:   18 Months to 6 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 29, 2014