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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: General Anesthesia

Treatments: Procedure: Tracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01007370

NM 2010-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

LMA-Fastrach

Active Comparator group

Description:

* 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

Treatment:

Procedure: Tracheal intubation

Procedure: Tracheal intubation

I-gel

Active Comparator group

Description:

* 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

Treatment:

Procedure: Tracheal intubation

Procedure: Tracheal intubation