ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

NCT ID: NCT00888875

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

i-gel

Intervention Type: DEVICE

insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically

2

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

Group Type: ACTIVE_COMPARATOR

ILMA

Intervention Type: DEVICE

Insertion after Induction. Insertion of tracheal tube over device

Interventions

i-gel

insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically

Intervention Type: DEVICE

ILMA

Insertion after Induction. Insertion of tracheal tube over device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Greif, M.D.

Role: STUDY_DIRECTOR

Department of Anesthesia, University Hospital Berne, Switzerland

Locations

University Hospital

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

Fast igel1

Identifier Type: -

Identifier Source: org_study_id