Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal

Study Overview
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Brief Summary
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The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.

Detailed Description
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Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study. The aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P < 0,05 is statistically significant.

Official Title
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LMA ProSeal & I-Gel : a Prospective Controlled Trial

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: Laryngeal mask insertion (LMA ProSeal)
* Device: Laryngeal mask insertion (I-Gel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight > 30 kg Surgery allowing the use of laryngeal mask as airway management Written informed consent Exclusion Criteria: Difficult intubation criteria (defined by French Anesthesia-Reanimation Society) Pulmonary disease Gastroesophageal reflux antecedent Coeliosurgery Inhalation risk Hiatus hernia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>LMA ProSeal | Device: Laryngeal mask insertion (LMA ProSeal)<br>* Laryngeal mask insertion<br>* Other names: LMA ProSeal;|
| Experimental: 2<br>I-Gel | Device: Laryngeal mask insertion (I-Gel)<br>* Laryngeal mask insertion<br>* Other names: I-Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate |  | At firste attempt of insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative morbidity |  | Perioperative period | 
| Airway sealing pressure |  | Once, when efficient ventilation is reached | 
| Accessibility for stomach tube insertion |  | Juste after laryngeal mask insertion | 
| Fibre-optic grade |  | After insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Laryngeal mask airway