ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Tracheal Intubation

Treatments: Device: ILMA; Device: i-gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00888875

Fast igel1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective operation with intubation
• ASA I-IV
• speaks German
• at least one predictor for difficult intubation

Exclusion criteria

• weight <30kg
• Risk Aspiration
• Risk bleeding orally
• known or highly suspected difficult mask ventilation
• Mouth opening < 20mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

1

Experimental group

Description:

Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube

Treatment:

Device: i-gel

2

Active Comparator group

Description:

Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube

Treatment:

Device: ILMA