ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tracheal Intubation

Intervention / Treatment
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* Device: i-gel
* Device: ILMA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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i-gel, Fastrach, intubation, fiberoptic, difficult airway, Patients undergoing elective surgery requiring tracheal intubation, Presenting at least one sign of difficult intubation