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Completed

NCT Number: NCT02769819

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

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

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Key information

Conditions

Intubation; Difficult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible fiberscope

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.

Primary outcomes

  1. Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.

    Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

    This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using a flexible fiberscope.

Secondary outcomes

  1. Time to successful intubation

    Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

  2. Number of attempts to successful intubation

    Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

  3. Score on the Intubation Difficulty Scale

    Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: BFO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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