NCT01265862

Brief Summary

The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia. The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an equal success rate of fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

December 21, 2010

Last Update Submit

August 22, 2012

Conditions

IntubationGeneral Anesthesia

Keywords

Tracheal intubationSupraglottic airway devicesPatients undergoing general anesthesia

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate of tracheal intubation

    After successful insertion of tracheal tube before the beginning of surgery

Secondary Outcomes (5)

  • Time needed for successful insertion of a supraglottic device

    After insertion of the device before the beginning of surgery

  • Time needed to obtain successful tracheal intubation

    After tracheal intubation before the beginning of surgery

  • First attempt success rate of supraglottic device insertion

    After insertion of the device before the beginning of surgery

  • Global success rate of supraglottic device insertion

    After insertion of the device before the beginning of surgery

  • Fibreoptic view following the supraglottic device insertion

    After insertion of the device before surgery

Study Arms (2)

LMA-Fastrach® and GlideRite® tube

ACTIVE COMPARATOR

* 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®, establishment of ventilation * Evaluation of glottic view through LMA-Fastrach® using fibrescope * Tracheal intubation with the GlideRite® tube through the LMA-Fastrach® * With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device

Procedure: Tracheal intubation through LMA-Fastrach®

I-gel® and GlideRite® tube

EXPERIMENTAL

* 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®, establishment of ventilation * Evaluation of glottic view through I-gel® using fibrescope * Tracheal intubation with the GlideRite® endotracheal tube through the I-gel® * With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device

Procedure: Tracheal intubation through I-gel®

Interventions

Tracheal intubation through LMA-Fastrach®PROCEDURE

Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube

LMA-Fastrach® and GlideRite® tube
Tracheal intubation through I-gel®PROCEDURE

Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube

I-gel® and GlideRite® tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

You may not qualify if:

  • American Society of Anesthesiologists (ASA) classification ≥ 4
  • Contraindications to muscle relaxation
  • Mouth opening less than 2 cm
  • Patients at increased risk of regurgitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

  • Nathalie Massicotte, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 23, 2010

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

CA(1)