NCT00626951

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 3, 2008

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

February 15, 2008

Last Update Submit

June 25, 2008

Conditions

Paralysis

Keywords

LMA SupremeLMA ProSealLaryngeal mask airwayVentilation

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure

    5 min

Secondary Outcomes (1)

  • Ease of insertion

    1 min

Study Arms (2)

1

EXPERIMENTAL

LMA Supreme

Device: LMA Supreme

2

EXPERIMENTAL

LMA ProSeal

Device: LMA ProSeal

Interventions

LMA SupremeDEVICE

Extraglottic airway devices

1
LMA ProSealDEVICE
2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

ParalysisRespiratory Aspiration

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Officials

  • Christian Keller, MD, MSc

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 29, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 3, 2008

Record last verified: 2008-06

Locations

AU(1)