NCT00888875

ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.

Detailed description

The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway device that is inserted blindly. It may be used to facilitate intubation and secure the airway in routine practice, in difficult airway scenarios or in emergency situations. Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the success rate. The i-gel™ is a newly developed supraglottic airway device and is also introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided. So far, prospective randomized controlled trials comparing their performance are not yet published. There are case reports about intubating over the i-gel. In this prospective, randomized, controlled trial, we are going to evaluate the performance of intubation through both devices. In 250 patients undergoing elective surgery, we will place either the ILMA or the i-gel according to randomization and then intubate with the help of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA stabilizer rod.

Conditions

• Tracheal Intubation

Interventions

Type	Name	Description
DEVICE	i-gel	insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically
DEVICE	ILMA	Insertion after Induction. Insertion of tracheal tube over device

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-04-28
• Last updated: 2014-03-12

Locations

1 site across 1 country: Switzerland