Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?
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|ClinicalTrials.gov Identifier: NCT01265862|
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : August 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Intubation General Anesthesia||Procedure: Tracheal intubation through LMA-Fastrach® Procedure: Tracheal intubation through I-gel®||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: LMA-Fastrach® and GlideRite® tube
Procedure: Tracheal intubation through LMA-Fastrach®
Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube
Experimental: I-gel® and GlideRite® tube
Procedure: Tracheal intubation through I-gel®
Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube
- First attempt success rate of tracheal intubation [ Time Frame: After successful insertion of tracheal tube before the beginning of surgery ]
- Time needed for successful insertion of a supraglottic device [ Time Frame: After insertion of the device before the beginning of surgery ]
- Time needed to obtain successful tracheal intubation [ Time Frame: After tracheal intubation before the beginning of surgery ]
- First attempt success rate of supraglottic device insertion [ Time Frame: After insertion of the device before the beginning of surgery ]
- Global success rate of supraglottic device insertion [ Time Frame: After insertion of the device before the beginning of surgery ]
- Fibreoptic view following the supraglottic device insertion [ Time Frame: After insertion of the device before surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265862
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montreal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Nathalie Massicotte, MD, FRCPC||Centre hospitalier de l'Université de Montréal (CHUM)|