Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?
NCT ID: NCT01265862
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-04-30
2012-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LMA-Fastrach® and GlideRite® tube
* Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
* Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
* Insertion of LMA-Fastrach®, establishment of ventilation
* Evaluation of glottic view through LMA-Fastrach® using fibrescope
* Tracheal intubation with the GlideRite® tube through the LMA-Fastrach®
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device
Tracheal intubation through LMA-Fastrach®
Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube
I-gel® and GlideRite® tube
* Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
* Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
* Insertion of I-gel®, establishment of ventilation
* Evaluation of glottic view through I-gel® using fibrescope
* Tracheal intubation with the GlideRite® endotracheal tube through the I-gel®
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device
Tracheal intubation through I-gel®
Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Exclusion Criteria
* Contraindications to muscle relaxation
* Mouth opening less than 2 cm
* Patients at increased risk of regurgitation
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Nathalie Massicotte, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Countries
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Other Identifiers
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NM2011-001
Identifier Type: -
Identifier Source: org_study_id