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

NCT ID: NCT02769819

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-09-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Intubation; Difficult

Keywords

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Flexible fiberscope

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Flexible fiberscope

Intervention Type DEVICE

* 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan R Williams, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

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Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31953669 (View on PubMed)

Other Identifiers

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16.051

Identifier Type: -

Identifier Source: org_study_id