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

University Hospital of Bordeaux

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Device: Laryngeal mask insertion (LMA ProSeal); Device: Laryngeal mask insertion (I-Gel)

Study type: Interventional

Funder types: Other

Identifiers

NCT00624403

CHUBX 2007/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

1

Active Comparator group

Description:

LMA ProSeal

Treatment:

Device: Laryngeal mask insertion (LMA ProSeal)

2

Experimental group

Description:

I-Gel

Treatment:

Device: Laryngeal mask insertion (I-Gel)