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Recruiting NCT06925009

Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Unicentric)

— Observational Difficult Videolaryngoscopy

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
The protocol lists: Ultrasound mesurements.
Who it may be relevant to
Registry conditions: Difficult Videolaryngoscopy. Basic parameters: 18 years — 90 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
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

Detailed description

Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.

Interventions

  • Diagnostic test Ultrasound mesurements
    Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.

Primary outcome measures

  • Distance from skin to Hyoid bone measured with lineal ultrasound probe [Time frame: 5 minutes]
  • Distance from skin to epiglottis measured with lineal ultrasound probe [Time frame: 5 minutes]
  • Tongue Thickness measured with convex probe [Time frame: 5 minutes]
  • Distance from Jaw to Hyoid bone distance measured with convex probe [Time frame: 5 minutes]
Secondary outcome measures (6)
  • Modified Mallampati Score Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. [Time frame: 1minute]
  • Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended [Time frame: 1minute]
  • Sternomental distance the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed [Time frame: 1minute]
  • Interincisor distance DIstance in centimeters between fornt incisors [Time frame: 1minute]
  • Upper Lip Bite Test upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip [Time frame: 1minute]
  • neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured [Time frame: 1minute]

Eligibility criteria

Inclusion criteria

  • Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Exclusion criteria

  • Obesity class II defined as a BMI greater than 35.
  • Pregnant.
  • Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
  • Abnormalities that condition anatomy alterations such as facial / cervical fractures.
  • Maxillofacial abnormalities
  • People who cannot give their consent

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

Study design

Observational model
Other

Study locations

Spain · 1 center
  • Clinica Universidad de Navarra — Madrid

Publications

  • Fernandez-Vaquero MA, Oyarzun-Silva R, Hernandez-Hernandez P, Gomez-Rios MA, Petrisor C, Falcetta S, Gomes SH, De Luis-Cabezon N. Airway coach project: development of a machine learning-based model using clinical and ultrasound parameters to support videolaryngoscopy strategy. BMC Anesthesiol. 2026 Jun 18. doi: 10.1186/s12871-026-03943-4. Online ahead of print. PMID 42316024

Identifiers

NCT: NCT06925009 · MAFV 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗