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
  Purpose

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 Intervention
Endotracheal Intubation
Device: Laryngeal mask insertion (LMA ProSeal)
Device: Laryngeal mask insertion (I-Gel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: LMA ProSeal & I-Gel : a Prospective Controlled Trial

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Insertion success rate [ Time Frame: At firste attempt of insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 700
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
LMA ProSeal
Device: Laryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
Other Name: LMA ProSeal
Experimental: 2
I-Gel
Device: Laryngeal mask insertion (I-Gel)
Laryngeal mask insertion
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624403

Locations
France
Uniersity Hospital, Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Anne-Marie CROS, Dr University Hospital, Bordeaux
  More Information

Publications:
Responsible Party: Jean-Pierre LEROY - Clinical Research and Innovation Director (General Director delegation), University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00624403     History of Changes
Other Study ID Numbers: CHUBX 2007/22
Study First Received: February 15, 2008
Last Updated: January 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Anesthesia
Laryngeal mask airway

ClinicalTrials.gov processed this record on October 19, 2014