Characteristics to Predict Successful Intubation With the Bonfils Fiberscope

Endotracheal Intubation Clinical Trial

Official title:

Identification of Morphological Characteristics to Predict Successful Intubation With the Bonfils Fiberscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975987
• Other study ID #: 13.182
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: July 17, 2014
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• Bonfils fiberscope

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphologic and morphometric predictors of successful tracheal intubation with the Bonfils fiberscope	This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using the Bonfils fiberscope.	Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes	Yes
Secondary	Time to successful intubation		Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes	Yes
Secondary	Number of attempts to successful intubation		Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes	Yes
Secondary	Score on the Intubation Difficulty Scale	To calculate the Intubation Difficulty Score the following variables will be collected: number of attempts, number of operators, necessity to use an alternative intubation technique, glottic visualization and effort needed to obtain optimal view of the glottis, necessity of external laryngeal pressure and vocal cords position during intubation.	Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes	Yes