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Clinical Trials/NCT07355608
NCT07355608
Not yet recruiting
Not Applicable

Prediction of Difficult Videolaryngoscopic Intubation and Development of a Dedicated Glottic View Score: A Multicentre Prospective Study

Diskapi Teaching and Research Hospital2 sites in 1 country4,977 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
4,977
Locations
2
Primary Endpoint
Failed first intubation attempt

Overview

Brief Summary

Background:

Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.

Objectives:

This study aims to:

  1. Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways.
  2. Create a glottic view scoring system specifically tailored to videolaryngoscopy.
  3. Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.

Detailed Description

Background:

Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.

Objectives:

This study aims to:

  1. Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways.
  2. Create a glottic view scoring system specifically tailored to videolaryngoscopy.
  3. Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.

Methods:

A prospective cohort of 4,977 patients will be enrolled. Patient and intubation related variables-including VL findings, airway features, clinical parameters, device, and procedural details-will be analyzed. Binary logistic regression will be employed to build the initial predictive model. In parallel, machine learning techniques (Random Forest, Support Vector Machine, XGBoost, LightGBM, etc.) will be applied to evaluate predictive performance. Comparative analysis will be conducted between the machine learning models and the logistic regression baseline.

Expected Impact:

The development of a robust predictive tool and an associated VL-specific glottic view score could enhance clinical decision making, particularly in identifying patients at risk of difficult or failed VL intubation. This may support early consideration of awake tracheal intubation, and use of standardized terminology and reduce complications associated with difficult airway management

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Both with normal or predicted difficult airways
  • Undergoing orotracheal intubation with a videolarygoscope

Exclusion Criteria

  • Rapid sequence intubation
  • Double lumen tube intubation

Outcomes

Primary Outcomes

Failed first intubation attempt

Time Frame: 2 minutes after anesthesia induction

Failed to intubate at firtst attempt

Difficult intubation

Time Frame: 2 minutes after anesthesia induction

Failed to intubate at 1-2 attempts and/or intubation duration longer than 120 second

Failed intubation

Time Frame: 2 minutes after anesthesia induction

Not able to intubate the patient

Intubation duration

Time Frame: 2 minutes after anesthesia induction

Time elapsed from entring the blade between the teeth to detecting an entidal carbondioxide trace

Glottic view description

Time Frame: 2 minutes after anesthesia induction

Vocal cords are fully visible Vocal cords are partially separately Vocal cords are not visible Cords are adducted Epiglottis is visible Epiglottis is large Epiglottis is small Epiglottis is edematous Epiglottis mass is present Arytenoids are visible Arytenoid luxation or subluxation Arytenoid edema Valecula problem (edema, Coffee grounds, etc., unable to insert a blade) Aryepiglottic plica pathology (edema, Coffee grounds scar) Laryngeal structures should be formed Glottic stenosis Laryngospasm

Secondary Outcomes

  • Percentil of glottic opening score(2 minutes after anesthesia induction)
  • Cormack lehanne score(2 minutes after anesthesia induction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DILEK YAZICIOGLU

Professor of Anesthesiology

Diskapi Teaching and Research Hospital

Study Sites (2)

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