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

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01007370
First received: November 3, 2009
Last updated: May 27, 2010
Last verified: May 2010
History of Changes

November 3, 2009
May 27, 2010
March 2010
May 2010   (final data collection date for primary outcome measure)
First attempt success rate of tracheal intubation. [ Time Frame: After successful insertion of tracheal tube ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01007370 on ClinicalTrials.gov Archive Site
  • Time needed for successful insertion of a supraglottic device. [ Time Frame: After insertion ] [ Designated as safety issue: Yes ]
  • First and total attempt success rate of supraglottic device insertion. [ Time Frame: After insertion ] [ Designated as safety issue: Yes ]
  • Total time and number of attempts needed to obtain successful tracheal intubation. [ Time Frame: After tracheal intubation ] [ Designated as safety issue: Yes ]
  • Fiberoptic view following the supraglottic device insertion. [ Time Frame: After insertion of the device ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Patients Undergoing Elective General Anesthesia.
  • 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: 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
    Intervention: Procedure: Tracheal intubation
  • 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
    Intervention: Procedure: Tracheal intubation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01007370
NM 2010-001
No
Nathalie Massicotte, Centre Hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Not Provided
Principal Investigator: Nathalie Massicotte, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP