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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007370
• Other study ID #: NM 2010-001
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: August 2, 2017
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: August 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• Tracheal intubation
Tracheal intubation through a supraglottic airway device(LMA-Fastrach).
• Tracheal intubation
Tracheal intubation through a supraglottic airway device(I-gel).

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate of tracheal intubation.		After successful insertion of tracheal tube
Secondary	Time needed for successful insertion of a supraglottic device.		After insertion
Secondary	First and total attempt success rate of supraglottic device insertion.		After insertion
Secondary	Total time and number of attempts needed to obtain successful tracheal intubation.		After tracheal intubation
Secondary	Fiberoptic view following the supraglottic device insertion.		After insertion of the device