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

LMA ProSeal & I-Gel : a Prospective Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Device: Laryngeal mask insertion (LMA ProSeal); Device: Laryngeal mask insertion (I-Gel)

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 Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Uniersity Hospital, Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; LMA ProSeal	Device: Laryngeal mask insertion (LMA ProSeal); Laryngeal mask insertion; Other Names: LMA ProSeal
Experimental: 2; I-Gel	Device: Laryngeal mask insertion (I-Gel); Laryngeal mask insertion; Other Names: I-Gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Anne-Marie CROS, Dr, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.
• Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.
• Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. doi: 10.1016/j.annfar.2006.06.009. Epub 2006 Jul 20. No abstract available. French.
• Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.
• Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20. doi: 10.1097/00000539-200010000-00046.
• Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7. doi: 10.1093/bja/88.2.296.
• Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83. doi: 10.1093/bja/aeg239.
• Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33. doi: 10.1093/bja/88.4.527.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimated): February 27, 2008

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Anesthesia; Laryngeal mask airway
• Other Study ID Numbers: CHUBX 2007/22; 2007-A01095-48 (Other Identifier: ANSM)