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

Schulthess Klinik

Status: Completed

Conditions: Complication of Device Insertion; Device Induced Injury; Necrosis, Pressure; Airway Morbidity

Treatments: Device: Laryngeal Mask Airway Supreme; Device: i-Gel extraglottic airway device

Study type: Interventional

Funder types: Other

Identifiers

NCT01367678

Schulthess_Anä_1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Laryngeal Mask Airway Supreme

Experimental group

Description:

Directly measured mucosal pressures

Treatment:

Device: Laryngeal Mask Airway Supreme

i-Gel

Experimental group

Description:

Directly measured mucosal pressures

Treatment:

Device: i-Gel extraglottic airway device