Clinical trial NCT01265862: Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
General Anesthesia
Keywords: Tracheal intubation
Supraglottic airway devices
Patients undergoing general anesthesia
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: First attempt success rate of tracheal intubation
timeFrame: After successful insertion of tracheal tube before the beginning of surgery
Secondary outcomes:
measure: Time needed for successful insertion of a supraglottic device
timeFrame: After insertion of the device before the beginning of surgery
measure: Time needed to obtain successful tracheal intubation
timeFrame: After tracheal intubation before the beginning of surgery
measure: First attempt success rate of supraglottic device insertion
timeFrame: After insertion of the device before the beginning of surgery
measure: Global success rate of supraglottic device insertion
timeFrame: After insertion of the device before the beginning of surgery
measure: Fibreoptic view following the supraglottic device insertion
timeFrame: After insertion of the device before surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Nathalie Massicotte, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: