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Completed

NCT Number: NCT01265862

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

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.

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Key information

Conditions

Intubation General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracheal intubation through LMA-Fastrach®

Procedure

Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube

Tracheal intubation through I-gel®

Procedure

Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube

Primary outcomes

  1. First attempt success rate of tracheal intubation

    Time frame: After successful insertion of tracheal tube before the beginning of surgery

Secondary outcomes

  1. Time needed for successful insertion of a supraglottic device

    Time frame: After insertion of the device before the beginning of surgery

  2. Time needed to obtain successful tracheal intubation

    Time frame: After tracheal intubation before the beginning of surgery

  3. First attempt success rate of supraglottic device insertion

    Time frame: After insertion of the device before the beginning of surgery

  4. Global success rate of supraglottic device insertion

    Time frame: After insertion of the device before the beginning of surgery

  5. Fibreoptic view following the supraglottic device insertion

    Time frame: After insertion of the device before surgery

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study 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?

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2010
Registry last updated
Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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