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

NCT06881589 | Recruiting

• 1 other identifier: MAFV 2
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difficult Videolaryngoscopy

Keywords

Ultrasound;; AI analyses; Difficult Videolaryngoscopy,

Outcome Measures

Primary Outcomes (4)

• 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 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.

  Immediately prior to induction of anesthesia

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

  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

  Immediately prior to induction of anesthesia

• Interincisor distance DIstance in centimeters between fornt incisors

  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

  Immediately prior to induction of anesthesia

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

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: March 18, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-09

Locations

ES (1)