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NCT01367678 Clinical Trial

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

Airway Morbidity Clinical Trial

Official title:
Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01367678
Other study ID # Schulthess_Anä_1
Secondary ID
Status Completed
Phase N/A
First received June 3, 2011
Last updated August 23, 2011
Start date May 2011
Est. completion date August 2011

Study information
Verified date August 2011
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority Austria : Federal Ministry for Labour, Health, and Social AffairsAustria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
• i-Gel extraglottic airway device
Directly measured mucosal pressures

Locations
Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol
Switzerland Christian Keller MD, M.Sc. Zürich

Sponsors (2)
Lead Sponsor Collaborator
Schulthess Klinik Medical University Innsbruck

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharyngeal mucosal pressure every 5 minutes during steady state anesthesia Yes
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