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

Schulthess Klinik

Status: Completed

Conditions: Adverse Anesthesia Outcome

Treatments: Procedure: Slotted Guedeltubus; Procedure: AuraGain

Study type: Interventional

Funder types: Other

Identifiers

NCT02570269

Schulthess_Anä_6

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

AuraGain

Active Comparator group

Description:

The patient will get a fiberoptic Intubation via the AuraGain larynxmask

Treatment:

Procedure: AuraGain

Slotted Guedeltubus

Placebo Comparator group

Description:

The patient will get a fiberoptic intubation via the slotted Guedeltubus

Treatment:

Procedure: Slotted Guedeltubus