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.

Study Overview

• Status: Recruiting
• Conditions: Difficult Videolaryngoscopy
• Intervention / Treatment: Diagnostic test: Ultrasound mesurements

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28027
      • Recruiting
      • Clinica Universidad de Navarra
      • Contact: Miguel Angel Fernandez-Vaquero, MD, PhD; Phone Number: 7633 +34913531920; Email: mfvaquero@unav.es
      • Sub-Investigator: Cristina Petrisor, MD
      • Sub-Investigator: Stefano Falcetta, MD
      • Sub-Investigator: Sara Gomes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient undergoing general anesthesia with videolaryngoscopy intubation; Patient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway.	Diagnostic test: Ultrasound mesurements; Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from skin to Hyoid bone measured with lineal ultrasound probe	Distance from skin to Hyoid bone measured with lineal ultrasound probe	Immediately prior to induction of anesthesia
Distance from skin to epiglottis measured with lineal ultrasound probe	Distance from skin to epiglottis measured with lineal ultrasound probe	Immediately prior to induction of anesthesia
Tongue Thickness measured with convex probe	Tongue Thickness measured with convex probe	Immediately prior to induction of anesthesia
Distance from Jaw to Hyoid bone distance measured with convex probe	Distance from Jaw to Hyoid bone distance measured with convex probe	Immediately prior to induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Modified Mallampati Score	Immediately prior to induction of anesthesia
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended	Thyromental distance	Immediately prior to induction of anesthesia
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	Sternomental distance	Immediately prior to induction of anesthesia
Interincisor distance DIstance in centimeters between fornt incisors	Interincisor distance	Immediately prior to induction of anesthesia
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	Upper Lip Bite Test	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	neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured	Immediately prior to induction of anesthesia

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: County Clinical Emergency Hospital Cluj-Napoca; Hospital Ancona; Hospital CUF Porto

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound;; AI analyses; Difficult Videolaryngoscopy,
• Other Study ID Numbers: MAFV 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No