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Completed

NCT Number: NCT00624403

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

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.

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Key information

Conditions

Endotracheal Intubation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniersity Hospital, Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal mask insertion (LMA ProSeal)

Device

Laryngeal mask insertion

Other names: LMA ProSeal

Laryngeal mask insertion (I-Gel)

Device

Laryngeal mask insertion

Other names: I-Gel

Primary outcomes

  1. Insertion success rate

    Time frame: At firste attempt of insertion

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

LMA ProSeal & I-Gel : a Prospective Controlled Trial

Acronym: I-Gel

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2008
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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