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

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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Key information

Conditions

Device Induced Injury Airway Morbidity Complication of Device Insertion Necrosis Necrosis, Pressure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck, Innsbruck, Tyrol, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal Mask Airway Supreme

Device

Directly measured mucosal pressures

Other names: Supreme

i-Gel extraglottic airway device

Device

Directly measured mucosal pressures

Other names: i-Gel

Primary outcomes

pharyngeal mucosal pressure

Time frame: every 5 minutes during steady state anesthesia

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

Medical University Innsbruck

Registry information

Official study title

Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 7, 2011
Registry last updated: Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed