NCT00624403

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

LMA ProSeal & I-Gel : a Prospective Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Endotracheal Intubation

Interventions

Type	Name	Description
DEVICE	Laryngeal mask insertion (LMA ProSeal)	Laryngeal mask insertion
DEVICE	Laryngeal mask insertion (I-Gel)	Laryngeal mask insertion

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2008-02-27
• Last updated: 2015-03-10

Locations

1 site across 1 country: France