Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

Medical University Innsbruck

Status: Completed

Conditions: Paralysis

Treatments: Device: LMA Supreme; Device: LMA ProSeal

Study type: Interventional

Funder types: Other

Identifiers

NCT00626951

07208763-1

Details and patient eligibility

About

The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

Full description

The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

Enrollment: 94 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiology physical status grade I-II
• Age 18-80 yr
• Elective gynecological surgery
• Supine position

Exclusion criteria

• Known or predicted difficult airway
• Body mass index >35 kg m-2
• Risk of aspiration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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94 participants in 2 patient groups

1

Experimental group

Description:

LMA Supreme

Treatment:

Device: LMA Supreme

2

Experimental group

Description:

LMA ProSeal

Treatment:

Device: LMA ProSeal