Laryngeal Mask Supreme™ Versus the I-gel™

Study Overview
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Brief Summary
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We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

Detailed Description
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The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

Official Title
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A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Conditions
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Patients Undergoing Elective General Anesthesia

Intervention / Treatment
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* Device: I-gel and LMA Supreme: supraglottic airway devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-3 patients undergoing elective operation Exclusion Criteria: Not speaking german or refusing to participate BMI >35, <50kg Planned operation time >4h High risk of aspiration Cervical spine disease, known difficult airway, mouth opening <20mm Upper respiratory tract symptoms in the previous 10 days Preoperative sore throat Poor dentition with high risk of damage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>crossover trial. insertion of both devices consecutively, computer randomized order | Device: I-gel and LMA Supreme: supraglottic airway devices<br>* Insertion of a supraglottic airway device<br>* Other names: Laryngeal Mask Supreme, supraglottic airway device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt success rate and time to success |  | during intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leak pressure |  | during intervention |