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Completed

NCT Number: NCT01007370

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.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tracheal intubation

Procedure

Tracheal intubation through a supraglottic airway device(LMA-Fastrach).

Primary outcomes

  1. First attempt success rate of tracheal intubation.

    Time frame: After successful insertion of tracheal tube

Secondary outcomes

  1. Time needed for successful insertion of a supraglottic device.

    Time frame: After insertion

  2. First and total attempt success rate of supraglottic device insertion.

    Time frame: After insertion

  3. Total time and number of attempts needed to obtain successful tracheal intubation.

    Time frame: After tracheal intubation

  4. Fiberoptic view following the supraglottic device insertion.

    Time frame: After insertion of the device

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2009
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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