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NCT Number: NCT06881589

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

This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location status: Recruiting

Location contact

Cristina Petrisor, MD

SUB_INVESTIGATOR

Miguel Angel Fernandez-Vaquero, MD, PhD

CONTACT

[email protected]

+34913531920 ext. 7633

Sara Gomes, MD

SUB_INVESTIGATOR

Stefano Falcetta, MD

SUB_INVESTIGATOR

About this study

Videolaryngoscopy is widely used for tracheal intubation in anaesthesia and critical care; however, variability in patient anatomy, operator experience, and institutional practice may influence videolaryngoscopy performance and strategy selection. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decision-making, particularly in diverse clinical environments.

This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.

The primary objective is to evaluate the performance and generalisability of multimodal predictive models developed using multicentre data. The study is designed to support the development and validation of data-driven decision-support tools for videolaryngoscopy planning. These tools are intended for research purposes and do not replace clinical judgement.

Who can participate

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

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

Treatment and study plan

Ultrasound mesurements

Diagnostic Test

Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.

Primary outcomes

  1. Distance from skin to Hyoid bone measured with lineal ultrasound probe

    Time frame: Immediately prior to induction of anesthesia

    Distance from skin to Hyoid bone measured with lineal ultrasound probe

  2. Distance from skin to epiglottis measured with lineal ultrasound probe

    Time frame: Immediately prior to induction of anesthesia

    Distance from skin to epiglottis measured with lineal ultrasound probe

  3. Tongue Thickness measured with convex probe

    Time frame: Immediately prior to induction of anesthesia

    Tongue Thickness measured with convex probe

  4. Distance from Jaw to Hyoid bone distance measured with convex probe

    Time frame: Immediately prior to induction of anesthesia

    Distance from Jaw to Hyoid bone distance measured with convex probe

Secondary outcomes

  1. 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: Immediately prior to induction of anesthesia

    Modified Mallampati Score

  2. Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended

    Time frame: Immediately prior to induction of anesthesia

    Thyromental distance

  3. 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: Immediately prior to induction of anesthesia

    Sternomental distance

  4. Interincisor distance DIstance in centimeters between fornt incisors

    Time frame: Immediately prior to induction of anesthesia

    Interincisor distance

  5. 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: Immediately prior to induction of anesthesia

    Upper Lip Bite Test

  6. neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured

    Time frame: Immediately prior to induction of anesthesia

    neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • County Clinical Emergency Hospital Cluj-Napoca
  • Hospital Ancona
  • Hospital CUF Porto

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Apr 15, 2026

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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