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Completed

NCT Number: NCT00888875

ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Bern, Canton of Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel

Device

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

ILMA

Device

Insertion after Induction. Insertion of tracheal tube over device

Primary outcomes

  1. successful intubation attempt with ventilation of both lungs

    Time frame: during intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2009
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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