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NCT Number: NCT06925009

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

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.

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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

Miguel Angel Fernandez-Vaquero, MD, PhD

CONTACT

[email protected]

+34913531920 ext. 7633

About this study

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.

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: 5 minutes

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

    Time frame: 5 minutes

  3. Tongue Thickness measured with convex probe

    Time frame: 5 minutes

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

    Time frame: 5 minutes

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: 1minute

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

    Time frame: 1minute

  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: 1minute

  4. Interincisor distance DIstance in centimeters between fornt incisors

    Time frame: 1minute

  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: 1minute

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

    Time frame: 1minute

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2025
Registry last updated
Jan 2, 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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