Characteristics to Predict Successful Intubation With the Bonfils Fiberscope

NCT ID: NCT01975987

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-07-31

Brief Summary

This study is designed to identify patients' features predictive of successful intubation using the Bonfils fiberscope.

Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils fiberscope.

Detailed Description

Endotracheal intubation is an important act in the practice of anesthesiology. Direct laryngoscopy is the most commonly used technique to accomplish this task. Airway characteristics predicting difficult intubation with direct laryngoscopy are well defined. Physical findings, such as Mallampati classification or measurements of the thyromental distance, mouth opening, and neck extension have been validated to help anticipate difficult situations. When direct laryngoscopy is strenuous, early conversion to an alternative technique might reduce the risk of airway compromise and associated morbidity.

Many intubation devices are now available and part of the anesthesiologist's task is to select the alternative approach best suited to each patient's specific features. Despite its use for both elective and unexpectedly difficult intubation, predictive criteria for successful airway management with the Bonfils fiberscope have not been proposed.

The purpose of this study is to identify patients' features, if any, that could predict successful intubation when using the Bonfils fiberscope for perioperative orotracheal intubation in an elective surgical population.

Conditions

Endotracheal Intubation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intubation with the Bonfils fiberscope

• Characteristics of patients will be assessed before induction of general anesthesia
• Glottic visualization will be evaluated by direct laryngoscopy.
• The endotracheal tube will be loaded onto the scope
• Intubation will be performed with the Bonfils fiberscope with the patient in supine position with head and neck in neutral position
• Bonfils fiberscope will be inserted from the right side of the patient's mouth, alongside the molars and advanced underneath the epiglottis. With the tip of the Bonfils in satisfactory position, the endotracheal tube will be advanced into the trachea using gentle rotary motions. The scope will then be removed.
• Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.

Group Type: EXPERIMENTAL

Bonfils fiberscope

Intervention Type: DEVICE

Interventions

Bonfils fiberscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Induction planned without neuromuscular blocking agents
• Need for a rapid sequence induction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud Robitaille, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

13.182

Identifier Type: -

Identifier Source: org_study_id