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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00624403
First received: February 15, 2008
Last updated: January 6, 2014
Last verified: January 2014

February 15, 2008
January 6, 2014
March 2008
December 2013   (final data collection date for primary outcome measure)
Insertion success rate [ Time Frame: At firste attempt of insertion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00624403 on ClinicalTrials.gov Archive Site
  • Perioperative morbidity [ Time Frame: Perioperative period ] [ Designated as safety issue: Yes ]
  • Airway sealing pressure [ Time Frame: Once, when efficient ventilation is reached ] [ Designated as safety issue: No ]
  • Accessibility for stomach tube insertion [ Time Frame: Juste after laryngeal mask insertion ] [ Designated as safety issue: No ]
  • Fibre-optic grade [ Time Frame: After insertion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Endotracheal Intubation
  • Device: Laryngeal mask insertion (LMA ProSeal)
    Laryngeal mask insertion
    Other Name: LMA ProSeal
  • Device: Laryngeal mask insertion (I-Gel)
    Laryngeal mask insertion
    Other Name: I-Gel
  • Active Comparator: 1
    LMA ProSeal
    Intervention: Device: Laryngeal mask insertion (LMA ProSeal)
  • Experimental: 2
    I-Gel
    Intervention: Device: Laryngeal mask insertion (I-Gel)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00624403
CHUBX 2007/22
No
Jean-Pierre LEROY - Clinical Research and Innovation Director (General Director delegation), University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Anne-Marie CROS, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP