ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888875
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : March 12, 2014
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Tracheal Intubation Device: i-gel Device: ILMA Not Applicable

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?
Study Start Date : July 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

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

Primary Outcome Measures :
  1. successful intubation attempt with ventilation of both lungs [ Time Frame: during intervention ]

Secondary Outcome Measures :
  1. insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects [ Time Frame: during intervention and first 24hours after operation ]
  2. simulated blind intubation in both groups [ Time Frame: during intervention ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888875

University Hospital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Study Director: Robert Greif, M.D. Department of Anesthesia, University Hospital Berne, Switzerland

Responsible Party: University Hospital Inselspital, Berne Identifier: NCT00888875     History of Changes
Other Study ID Numbers: Fast igel1
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by University Hospital Inselspital, Berne:
difficult airway
Patients undergoing elective surgery requiring tracheal intubation
Presenting at least one sign of difficult intubation