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

Study Overview
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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.

Official Title
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Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Procedure: AuraGain
* Procedure: Slotted Guedeltubus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AuraGain<br>The patient will get a fiberoptic Intubation via the AuraGain larynxmask | Procedure: AuraGain<br>* Fiberoptic Intubation<br>|
| Placebo Comparator: Slotted Guedeltubus<br>The patient will get a fiberoptic intubation via the slotted Guedeltubus | Procedure: Slotted Guedeltubus<br>* Fiberoptic Intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time to complete the Intubation in seconds | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation attempts | The number of intubation attempts will be recorded (eg 1, 2, 3...) | Intraoperative | 
| Esophagal Intubation attempts | The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...) | Intraoperative | 
| Resistance measurement of the Insertion as assessed by a four point scoring system | 1/2/3/4 | Intraoperative | 
| Position of the mask as assessed by the Brimacombe Score | 4/3/2/1 | Intraoperative | 
| Pain after Intubation as assessed by a Numeric Rating Scale | mild/moderate/severe | Intraoperative/2h postoperative/24h postoperative | 
| AE/Complications | Occuring AE/Complications will be recorded | Intraoperative/postoperative until 24h |