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

Not Applicable

Completed

• Conditions: Endotracheal Intubation
• Interventions: Device: Laryngeal mask insertion (LMA ProSeal); Device: Laryngeal mask insertion (I-Gel)

• Registration Number: NCT00624403
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-27
• Study Start: 2008-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Laryngeal mask insertion (LMA ProSeal)	LMA ProSeal
2	Laryngeal mask insertion (I-Gel)	I-Gel

Primary Outcome Measures

Name	Time	Method
Insertion success rate	At firste attempt of insertion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uniersity Hospital, Bordeaux; 🇫🇷 Bordeaux, France