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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
  Purpose

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.


Condition Intervention
Patients Undergoing Elective General Anesthesia.
 Procedure: Tracheal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • First attempt success rate of tracheal intubation. [ Time Frame: After successful insertion of tracheal tube ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 160
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: Tracheal intubation
Tracheal intubation through a supraglottic airway device(LMA-Fastrach).
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
 Procedure: Tracheal intubation
Tracheal intubation through a supraglottic airway device(I-gel).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007370

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Nathalie Massicotte, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Nathalie Massicotte, Centre Hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01007370     History of Changes
Other Study ID Numbers: NM 2010-001
Study First Received: November 3, 2009
Last Updated: May 27, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
tracheal intubation
supraglottic airway devices

ClinicalTrials.gov processed this record on June 18, 2013