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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

June 3, 2011
August 23, 2011
May 2011
August 2011   (final data collection date for primary outcome measure)
pharyngeal mucosal pressure [ Time Frame: every 5 minutes during steady state anesthesia ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01367678 on ClinicalTrials.gov Archive Site
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Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
  • Device Induced Injury
  • Necrosis, Pressure
  • Complication of Device Insertion
  • Airway Morbidity
  • Device: Laryngeal Mask Airway Supreme
    Directly measured mucosal pressures
    Other Name: Supreme
  • Device: i-Gel extraglottic airway device
    Directly measured mucosal pressures
    Other Name: i-Gel
  • Experimental: Laryngeal Mask Airway Supreme
    Directly measured mucosal pressures
    Intervention: Device: Laryngeal Mask Airway Supreme
  • Experimental: i-Gel
    Directly measured mucosal pressures
    Intervention: Device: i-Gel extraglottic airway device
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Female
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Switzerland
 
NCT01367678
Schulthess_Anä_1
Yes
ChristianKeller, Schulthess Klinik
Schulthess Klinik
Medical University Innsbruck
Study Director: Christian Keller, MD, M.Sc. Schulthess Klinik
Schulthess Klinik
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP