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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 280

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

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	Time Frame
Distance from skin to Hyoid bone measured with lineal ultrasound probe	5 minutes
Distance from skin to epiglottis measured with lineal ultrasound probe	5 minutes
Tongue Thickness measured with convex probe	5 minutes
Distance from Jaw to Hyoid bone distance measured with convex probe	5 minutes

Secondary Outcome Measures

Outcome Measure	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.	1minute
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended	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	1minute
Interincisor distance DIstance in centimeters between fornt incisors	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	1minute
neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured	1minute

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound;Difficult Videolaryngoscopy; Machine Learning
• Other Study ID Numbers: MAFV 1

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