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Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

NCT ID: NCT00626951

Last Updated: 2008-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-03-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Paralysis

Keywords

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LMA Supreme LMA ProSeal Laryngeal mask airway Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1

LMA Supreme

Group Type EXPERIMENTAL

LMA Supreme

Intervention Type DEVICE

Extraglottic airway devices

2

LMA ProSeal

Group Type EXPERIMENTAL

LMA ProSeal

Intervention Type DEVICE

Interventions

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LMA Supreme

Extraglottic airway devices

Intervention Type DEVICE

LMA ProSeal

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Medical University Innsbruck

Principal Investigators

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Christian Keller, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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07208763-1

Identifier Type: -

Identifier Source: org_study_id