Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

NCT ID: NCT02458794

Last Updated: 2015-07-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-04-30

Brief Summary

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The Ambu-Aura GainTM 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, 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 Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Detailed Description

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Conditions

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Airway Morbidity

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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LMA SupremeTM

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Group Type ACTIVE_COMPARATOR

function tests

Intervention Type PROCEDURE

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

LMA SupremeTM

Intervention Type DEVICE

Ambu-Aura GainTM

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Group Type ACTIVE_COMPARATOR

function tests

Intervention Type PROCEDURE

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

Ambu-Aura GainTM

Intervention Type DEVICE

Interventions

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function tests

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

Intervention Type PROCEDURE

LMA SupremeTM

Intervention Type DEVICE

Ambu-Aura GainTM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA 1 or 2
* Age 19-65 yr
* Written informed consent

Exclusion Criteria

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

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Bozen

OTHER

Sponsor Role collaborator

Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Keller, MD MSc

Role: STUDY_CHAIR

Schulthess Klinik

Locations

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Zentralkrankenhaus Bozen

Bolzano, , Italy

Site Status

Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Italy Switzerland

Central Contacts

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Christian Keller, MD MSc

Role: CONTACT

++41443857462

Facility Contacts

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Lukas Gasteiger, MD

Role: primary

Christian Keller, MD, M.Sc.

Role: primary

+41443857462

Other Identifiers

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Schulthess_Anä_5

Identifier Type: -

Identifier Source: org_study_id

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