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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624403
Recruitment Status : Completed
First Posted : February 27, 2008
Last Update Posted : March 10, 2015
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Device: Laryngeal mask insertion (LMA ProSeal) Device: Laryngeal mask insertion (I-Gel) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: LMA ProSeal & I-Gel : a Prospective Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: 1
LMA ProSeal
Device: Laryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
Other Name: LMA ProSeal

Experimental: 2
Device: Laryngeal mask insertion (I-Gel)
Laryngeal mask insertion
Other Name: I-Gel

Primary Outcome Measures :
  1. Insertion success rate [ Time Frame: At firste attempt of insertion ]

Secondary Outcome Measures :
  1. Perioperative morbidity [ Time Frame: Perioperative period ]
  2. Airway sealing pressure [ Time Frame: Once, when efficient ventilation is reached ]
  3. Accessibility for stomach tube insertion [ Time Frame: Juste after laryngeal mask insertion ]
  4. Fibre-optic grade [ Time Frame: After insertion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00624403

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Uniersity Hospital, Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Anne-Marie CROS, Dr University Hospital, Bordeaux
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Responsible Party: Jean-Pierre LEROY - Clinical Research and Innovation Director (General Director delegation), University Hospital, Bordeaux Identifier: NCT00624403    
Other Study ID Numbers: CHUBX 2007/22
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: January 2014
Keywords provided by University Hospital, Bordeaux:
Laryngeal mask airway