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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
  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:


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
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: 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
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 20, 2014