Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?

General Anesthesia Clinical Trial

Official title:

Comparison of LMA-Fastrach® and I-gel® for Tracheal Intubation: Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Success Rate?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265862
• Other study ID #: NM2011-001
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: August 22, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an equal success rate of fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.

Description:

Supraglottic airway devices such as LMA-Fastrach® and I-gel® provide patent airways during general anesthesia.

The LMA-Fastrach® is designed to provide a conduit for blind or fiberscopically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.

The I-gel® is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel® is easy to insert and that limited experience is needed before a high success insertion rate is obtained. A recent study conducted in our center compared the LMA-Fastrach® to the I-gel® supraglottic airway device. Our results showed a lower success intubation rate in the I-gel® group. We noticed that there was a tendency for the endotracheal tube to impinge on the posterior and lateral aspect of the larynx. The endotracheal tube used for intubation in our study was a standard polyvinyl chloride (PVC) tube. We believe that an endotracheal tube with a flexible tip(GlideRite®) would increase the intubation success rate through the I-gel® device. However, based on our clinical experience with the GlideRite® tube, blind tracheal intubation through the I-gel® airway device may be associated with a low success rate related to a lack of rigidity of its tip. Its use in combination with a fibrescope could compensate for this weakness. A recent study performed on mannequins showed a comparable success intubation rate of 99% for the I-gel® and LMA-Fastrach® when associated to a fibrescope.

In this prospective randomized study, we will compare the performance of the LMA-Fastrach® and the I-gel® associated with a GlideRite® endotracheal tube for fiberoptic tracheal intubation in patients undergoing elective surgery under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) classification = 4

• Contraindications to muscle relaxation

• Mouth opening less than 2 cm

• Patients at increased risk of regurgitation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia
• Intubation

Intervention

Procedure:
• Tracheal intubation through LMA-Fastrach®
Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube
• Tracheal intubation through I-gel®
Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate of tracheal intubation		After successful insertion of tracheal tube before the beginning of surgery	Yes
Secondary	Time needed for successful insertion of a supraglottic device		After insertion of the device before the beginning of surgery	Yes
Secondary	Time needed to obtain successful tracheal intubation		After tracheal intubation before the beginning of surgery	Yes
Secondary	First attempt success rate of supraglottic device insertion		After insertion of the device before the beginning of surgery	Yes
Secondary	Global success rate of supraglottic device insertion		After insertion of the device before the beginning of surgery	Yes
Secondary	Fibreoptic view following the supraglottic device insertion		After insertion of the device before surgery	Yes