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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02769819
Acronym
BFO
Enrollment
420
Registered
2016-05-12
Start date
2016-10-31
Completion date
2017-09-12
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult

Keywords

Flexible fiberscope

Brief summary

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

Interventions

DEVICEFlexible 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.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutesThis study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using a flexible fiberscope.

Secondary

MeasureTime frameDescription
Time to successful intubationPatients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Number of attempts to successful intubationPatients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Score on the Intubation Difficulty ScalePatients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutesTo 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026