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A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

NCT ID: NCT01575236

Last Updated: 2012-08-08

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Detailed Description

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The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Conditions

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Adverse Anesthesia Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Guardian

Guardian Laryngeal Mask

Group Type EXPERIMENTAL

Guardian Laryngeal Mask

Intervention Type DEVICE

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Supreme

Supreme Laryngeal Mask Airway

Group Type EXPERIMENTAL

Supreme Laryngeal Mask Airway

Intervention Type DEVICE

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Interventions

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Guardian Laryngeal Mask

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Intervention Type DEVICE

Supreme Laryngeal Mask Airway

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Intervention Type DEVICE

Other Intervention Names

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Guardian Laryngeal Mask, Umedaes Supreme Laryngeal Mask Airway, LMA Deutschland GmbH

Eligibility Criteria

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Inclusion Criteria

* ASA 1 or 2
* Age 18-75 yr
* Written informed consent

Exclusion Criteria

* Difficult airway
* Non fasted
* BMI \> 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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ChristianKeller

MD, M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Keller, MD MSc

Role: STUDY_CHAIR

Anästhesie Schulthess Klinik

Locations

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Universitätsklinik für Anästhesie

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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Schulthess_Anä_3

Identifier Type: OTHER

Identifier Source: secondary_id

Schulthess_Anä_3

Identifier Type: -

Identifier Source: org_study_id