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

NCT01007370 | Completed

• 1 other identifier: NM 2010-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Keywords

tracheal intubation; supraglottic airway devices

Outcome Measures

Primary Outcomes (1)

• First attempt success rate of tracheal intubation.

  After successful insertion of tracheal tube

Secondary Outcomes (4)

• Time needed for successful insertion of a supraglottic device.

  After insertion

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

  After insertion

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

  After tracheal intubation

• Fiberoptic view following the supraglottic device insertion.

  After insertion of the device

Study Arms (2)

LMA-Fastrach

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 (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

I-gel

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 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

Interventions

Tracheal intubation PROCEDURE

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

LMA-Fastrach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• ASA physical status 1-3
• Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

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

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

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: November 3, 2009
• First Posted: November 4, 2009
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

CA (1)