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Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway (Supreme)

Primary Purpose

Paralysis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
LMA Supreme
LMA ProSeal
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralysis focused on measuring LMA Supreme, LMA ProSeal, Laryngeal mask airway, Ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

LMA Supreme

LMA ProSeal

Outcomes

Primary Outcome Measures

Oropharyngeal leak pressure

Secondary Outcome Measures

Ease of insertion

Full Information

First Posted
February 15, 2008
Last Updated
June 25, 2008
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT00626951
Brief Title
Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway
Acronym
Supreme
Official Title
The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis
Keywords
LMA Supreme, LMA ProSeal, Laryngeal mask airway, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
LMA Supreme
Arm Title
2
Arm Type
Experimental
Arm Description
LMA ProSeal
Intervention Type
Device
Intervention Name(s)
LMA Supreme
Intervention Description
Extraglottic airway devices
Intervention Type
Device
Intervention Name(s)
LMA ProSeal
Primary Outcome Measure Information:
Title
Oropharyngeal leak pressure
Time Frame
5 min
Secondary Outcome Measure Information:
Title
Ease of insertion
Time Frame
1 min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Keller, MD, MSc
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

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Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

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