Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients

August 23, 2011 updated by: ChristianKeller, Schulthess Klinik

Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.

Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.

Insertion success rate and oropharyngeal leak pressure were also measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck
  • Switzerland
      • Zürich, Switzerland, 8008
        • Christian Keller MD, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I/II
  • female
  • age 19-65 years

Exclusion Criteria:

  • < 19 years
  • had a known or predicted difficult airway
  • a body mass index > 35 kg m-2, or
  • were at risk of aspiration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
Device: Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
Other Names:
  • Supreme
Experimental: i-Gel
Directly measured mucosal pressures
Device: i-Gel extraglottic airway device
Directly measured mucosal pressures
Other Names:
  • i-Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pharyngeal mucosal pressure
Time Frame: every 5 minutes during steady state anesthesia
every 5 minutes during steady state anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Collaborators

Medical University Innsbruck

Investigators

  • Study Director: Christian Keller, MD, M.Sc., Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

August 24, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schulthess_Anä_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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