Clinical trial NCT00888875: ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation
Official title: Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: i-gel
Fastrach
intubation
fiberoptic
difficult airway
Patients undergoing elective surgery requiring tracheal intubation
Presenting at least one sign of difficult intubation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: successful intubation attempt with ventilation of both lungs
timeFrame: during intervention
Secondary outcomes:
measure: insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects
timeFrame: during intervention and first 24hours after operation
measure: simulated blind intubation in both groups
timeFrame: during intervention
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Department of Anesthesia, University Hospital Berne, Switzerland
name: Robert Greif, M.D.
role: STUDY_DIRECTOR
References: