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

Endotracheal Intubation Clinical Trial

— I-Gel  

Official title:

LMA ProSeal & I-Gel : a Prospective Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624403
• Other study ID #: CHUBX 2007/22
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: March 9, 2015
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• Laryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
• Laryngeal mask insertion (I-Gel)
Laryngeal mask insertion

Locations

Country	Name	City	State
France	Uniersity Hospital, Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (8)

Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. Epub 2006 Jul 20. French. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion success rate		At firste attempt of insertion	No
Secondary	Perioperative morbidity		Perioperative period	Yes
Secondary	Airway sealing pressure		Once, when efficient ventilation is reached	No
Secondary	Accessibility for stomach tube insertion		Juste after laryngeal mask insertion	No
Secondary	Fibre-optic grade		After insertion	No