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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01265862
First received: December 21, 2010
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention
Intubation
General Anesthesia
Procedure: Tracheal intubation through LMA-Fastrach®
Procedure: Tracheal intubation through I-gel®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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?

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • First attempt success rate of tracheal intubation [ Time Frame: After successful insertion of tracheal tube before the beginning of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time needed for successful insertion of a supraglottic device [ Time Frame: After insertion of the device before the beginning of surgery ] [ Designated as safety issue: Yes ]
  • Time needed to obtain successful tracheal intubation [ Time Frame: After tracheal intubation before the beginning of surgery ] [ Designated as safety issue: Yes ]
  • First attempt success rate of supraglottic device insertion [ Time Frame: After insertion of the device before the beginning of surgery ] [ Designated as safety issue: Yes ]
  • Global success rate of supraglottic device insertion [ Time Frame: After insertion of the device before the beginning of surgery ] [ Designated as safety issue: Yes ]
  • Fibreoptic view following the supraglottic device insertion [ Time Frame: After insertion of the device before surgery ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
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
  • 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
Procedure: Tracheal intubation through I-gel®
Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265862

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Nathalie Massicotte, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01265862     History of Changes
Other Study ID Numbers: NM2011-001
Study First Received: December 21, 2010
Last Updated: August 22, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Tracheal intubation
Supraglottic airway devices
Patients undergoing general anesthesia

ClinicalTrials.gov processed this record on August 21, 2014