ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00888875
First received: April 27, 2009
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Tracheal Intubation
Device: i-gel
Device: ILMA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • successful intubation attempt with ventilation of both lungs [ Time Frame: during intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • simulated blind intubation in both groups [ Time Frame: during intervention ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888875

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

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00888875     History of Changes
Other Study ID Numbers: Fast igel1
Study First Received: April 27, 2009
Last Updated: March 11, 2014
Health Authority: Switzerland: Federal Office of Public Health

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

ClinicalTrials.gov processed this record on August 18, 2014