Identification of Morphological Characteristics to Predict Difficult Endotracheal Intubation Using a Flexible Fiberscope (BFO)

This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Device: Flexible 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 with the direct laryngoscope. When direct laryngoscopy is difficult, early conversion to an alternative technique reduces the risk of airway compromise and associated morbidity.

Many alternative 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 flexible fiberscope have not been developed.

The purpose of this study is to identify patient morphometric or morphological characteristics, if any, that could predict difficult intubation when using the flexible fiberscope for perioperative tracheal intubation in an elective surgical population.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intubation with a flexible fiberscope; Following induction of general anesthesia and administration of a neuromuscular blocking agent, intubation will be performed using a flexible fiberscope.

Device: Flexible 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 after silicon spray lubrication; Intubation will be performed with the flexible fiberscope with the patient in supine position with head and neck in neutral position; With the tip of the fiberscope in satisfactory position, the endotracheal tube will be advanced into the trachea. The scope will then be removed.; Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.	This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using a flexible fiberscope.	Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful intubation		Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Number of attempts to successful intubation		Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Score on the Intubation Difficulty Scale	To calculate the Intubation Difficulty Scale 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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Stephan R Williams, MD, PhD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• Toure T, Williams SR, Kerouch M, Ruel M. Patient factors associated with difficult flexible bronchoscopic intubation under general anesthesia: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):706-714. doi: 10.1007/s12630-020-01568-w. Epub 2020 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 12, 2017
• Study Completion (Actual): September 12, 2017

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Flexible fiberscope
• Other Study ID Numbers: 16.051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED