Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.

The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: Tracheal intubation; Procedure: Tracheal intubation

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 fiberoptically 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.

In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 and older
• ASA physical status 1-3
• Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

• ASA physical status 4-5
• Contraindications to muscle relaxation
• Anticipated or known difficult intubation or ventilation
• Patients with limited mouth opening (less than 2 cm)
• Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LMA-Fastrach; 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 (sizes 3,4 or 5), establishment of ventilation; Evaluation of glottic view through LMA-Fastrach using fibrescope (one out of ten patients); Tracheal intubation through the LMA-Fastrach; With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device	Procedure: Tracheal intubation; Tracheal intubation through a supraglottic airway device(LMA-Fastrach).; Procedure: Tracheal intubation; Tracheal intubation through a supraglottic airway device(I-gel).
Active Comparator: I-gel; 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 (sizes 3,4 or 5), establishment of ventilation; Evaluation of glottic view through I-gel using fibrescope (one out of ten patients); Tracheal intubation through the I-gel; With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device	Procedure: Tracheal intubation; Tracheal intubation through a supraglottic airway device(LMA-Fastrach).; Procedure: Tracheal intubation; Tracheal intubation through a supraglottic airway device(I-gel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
First attempt success rate of tracheal intubation.	After successful insertion of tracheal tube

Secondary Outcome Measures

Outcome Measure	Time Frame
Time needed for successful insertion of a supraglottic device.	After insertion
First and total attempt success rate of supraglottic device insertion.	After insertion
Total time and number of attempts needed to obtain successful tracheal intubation.	After tracheal intubation
Fiberoptic view following the supraglottic device insertion.	After insertion of the device

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: supraglottic airway devices; tracheal intubation
• Other Study ID Numbers: NM 2010-001