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

This study has been completed.
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01367678
First received: June 3, 2011
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Device Induced Injury
Necrosis, Pressure
Complication of Device Insertion
Airway Morbidity
 Device: Laryngeal Mask Airway Supreme
Device: i-Gel extraglottic airway device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Resource links provided by NLM:

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • pharyngeal mucosal pressure [ Time Frame: every 5 minutes during steady state anesthesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
 Device: Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
Other Name: Supreme
Experimental: i-Gel
Directly measured mucosal pressures
 Device: i-Gel extraglottic airway device
Directly measured mucosal pressures
Other Name: i-Gel

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367678

Locations
Austria
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Switzerland
Christian Keller MD, M.Sc.
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Medical University Innsbruck
Investigators
Study Director: Christian Keller, MD, M.Sc. Schulthess Klinik
  More Information

No publications provided

Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01367678     History of Changes
Other Study ID Numbers: Schulthess_Anä_1
Study First Received: June 3, 2011
Last Updated: August 23, 2011
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Pressure Ulcer
Necrosis
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013