ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888875
• Other study ID #: Fast igel1
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: March 11, 2014
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2014
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• i-gel
insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically
• ILMA
Insertion after Induction. Insertion of tracheal tube over device

Locations

Country	Name	City	State
Switzerland	University Hospital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful intubation attempt with ventilation of both lungs		during intervention	No
Secondary	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	Yes
Secondary	simulated blind intubation in both groups		during intervention	No