Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus

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

2015-12-31

Study Completion Date

2016-03-31

Brief Summary

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The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.

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Detailed Description

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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

DOUBLE

Participants Investigators

Study Groups

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AuraGain

The patient will get a fiberoptic Intubation via the AuraGain larynxmask

Group Type ACTIVE_COMPARATOR

AuraGain

Intervention Type PROCEDURE

Fiberoptic Intubation

Slotted Guedeltubus

The patient will get a fiberoptic intubation via the slotted Guedeltubus

Group Type PLACEBO_COMPARATOR

Slotted Guedeltubus

Intervention Type PROCEDURE

Fiberoptic Intubation

Interventions

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AuraGain

Fiberoptic Intubation

Intervention Type PROCEDURE

Slotted Guedeltubus

Fiberoptic Intubation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18
* ASA 1 -2
* Surgery of the shoulder, elbow, hand, hip, knee or foot
* Signed consent form

Exclusion Criteria

* Patients with expected difficulties regarding to the intubation
* Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
* Not sober
* Increased risk of aspiration
* BMI \> 35 kg/m2
* Acute disease which could affect the suitability of the anesthesia
* Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
* Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
* Drug abuse in the recent past
* Legal incompetence

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes