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Not yet recruiting NCT07355608

Videolaryngoscopic Difficult ıntubation and Glottic View Score: A Multicentre Prospective Study

Observational Airway Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Airway Management. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Failed first intubation attempt [Time frame: 2 minutes after anesthesia induction]
  • Difficult intubation [Time frame: 2 minutes after anesthesia induction]
  • Failed intubation [Time frame: 2 minutes after anesthesia induction]
  • Intubation duration [Time frame: 2 minutes after anesthesia induction]
  • Glottic view description [Time frame: 2 minutes after anesthesia induction]
Secondary outcome measures (2)
  • Percentil of glottic opening score [Time frame: 2 minutes after anesthesia induction]
  • Cormack lehanne score [Time frame: 2 minutes after anesthesia induction]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Rapid sequence intubation
  • Double lumen tube intubation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 2 centers
  • Etlik City Hospital — Ankara
  • Akdeniz University Medical Faculty — Antalya

Publications

  • Xia M, Jin C, Zheng Y, Wang J, Zhao M, Cao S, Xu T, Pei B, Irwin MG, Lin Z, Jiang H. Deep learning-based facial analysis for predicting difficult videolaryngoscopy: a feasibility study. Anaesthesia. 2024 Apr;79(4):399-409. doi: 10.1111/anae.16194. Epub 2023 Dec 13. PMID 38093485
  • O'Loughlin EJ, Swann AD, English JD, Ramadas R. Accuracy, intra- and inter-rater reliability of three scoring systems for the glottic view at videolaryngoscopy. Anaesthesia. 2017 Jul;72(7):835-839. doi: 10.1111/anae.13837. Epub 2017 Mar 24. PMID 28337769

Identifiers

NCT: NCT07355608 · Etlik City Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗