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)™ ?

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Device: i-gel; Device: ILMA

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube	Device: i-gel; insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically
Active Comparator: 2; Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube	Device: ILMA; Insertion after Induction. Insertion of tracheal tube over device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
successful intubation attempt with ventilation of both lungs	during intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects	during intervention and first 24hours after operation
simulated blind intubation in both groups	during intervention

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Director: Robert Greif, M.D., Department of Anesthesia, University Hospital Berne, Switzerland

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: intubation; difficult airway; fiberoptic; i-gel; Fastrach; Patients undergoing elective surgery requiring tracheal intubation; Presenting at least one sign of difficult intubation
• Other Study ID Numbers: Fast igel1