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

NCT06925009 | Recruiting

• 1 other identifier: MAFV 1
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difficult Videolaryngoscopy

Keywords

Ultrasound;Difficult Videolaryngoscopy; Machine Learning

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (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.

  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

Study Arms (1)

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

Interventions

Ultrasound mesurements DIAGNOSTIC_TEST

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

Patient undergoing general anesthesia with videolaryngoscopy intubation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Madrid, Madrid, 28027, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 13, 2025
• Study Start: January 27, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-01

Locations

ES (1)