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

Not Applicable

Completed

• Conditions: General Anesthesia

• Registration Number: NCT01007370
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First attempt success rate of tracheal intubation.	After successful insertion of tracheal tube

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame; 🇨🇦 Montréal, Quebec, Canada