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ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888875
Enrollment
240
Registered
2009-04-28
Start date
2008-07-31
Completion date
2010-05-31
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEi-gel

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

DEVICEILMA

Insertion after Induction. Insertion of tracheal tube over device

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
successful intubation attempt with ventilation of both lungsduring intervention

Secondary

MeasureTime frame
insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effectsduring intervention and first 24hours after operation
simulated blind intubation in both groupsduring intervention

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026