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RecruitingNCT06881589Updated Apr 15, 2026

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

An observational study in Difficult Videolaryngoscopy, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Difficult Videolaryngoscopy

Keywords

  • Ultrasound;
  • AI analyses
  • Difficult Videolaryngoscopy,
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In context

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients (male or female) , aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the is required authorizing its inclusion in the study.

Exclusion criteria

Exclusion Criteria:

  • Obesity class II defined as a 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testUltrasound mesurements

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

06

What researchers measure

Primary outcomes

  1. Distance from skin to Hyoid bone measured with lineal ultrasound probe

    Distance from skin to Hyoid bone measured with lineal ultrasound probe

    Time frame: Immediately prior to induction of anesthesia

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

    Distance from skin to epiglottis measured with lineal ultrasound probe

    Time frame: Immediately prior to induction of anesthesia

  3. Tongue Thickness measured with convex probe

    Tongue Thickness measured with convex probe

    Time frame: Immediately prior to induction of anesthesia

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

    Distance from Jaw to Hyoid bone distance measured with convex probe

    Time frame: Immediately prior to induction of anesthesia

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.

    Modified Mallampati Score

    Time frame: Immediately prior to induction of anesthesia

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

    Thyromental distance

    Time frame: Immediately prior to induction of anesthesia

  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

    Sternomental distance

    Time frame: Immediately prior to induction of anesthesia

  4. Interincisor distance DIstance in centimeters between fornt incisors

    Interincisor distance

    Time frame: Immediately prior to induction of anesthesia

  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

    Upper Lip Bite Test

    Time frame: Immediately prior to induction of anesthesia

  6. 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

    Time frame: Immediately prior to induction of anesthesia

07

Study locations

1 of 1 sites recruiting
  • Clinica Universidad de Navarra
    Madrid, Madrid 28027, Spain
    Recruiting
    • Miguel Angel Fernandez-Vaquero, MD, PhD · Contactmfvaquero@unav.es · +34913531920
    • Cristina Petrisor, MD · Sub investigator
    • Stefano Falcetta, MD · Sub investigator
    • Sara Gomes, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06881589
Collaborators
County Clinical Emergency Hospital Cluj-Napoca, Hospital Ancona, Hospital CUF Porto
Responsible party
Sponsor
First posted
Mar 18, 2025
Start date
Jan 27, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Apr 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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