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

Intubation; Difficult Clinical Trial

— BFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769819
• Other study ID #: 16.051
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: October 6, 2017
• Start date: October 2016
• Est. completion date: September 12, 2017

Study information

• Verified date: October 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

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.

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 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	Time to successful intubation		Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
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
Secondary	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