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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06881589
Enrollment
210
Registered
2025-03-18
Start date
2025-01-27
Completion date
2026-09-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Videolaryngoscopy

Keywords

Ultrasound;, AI analyses, Difficult Videolaryngoscopy,

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.

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.

Interventions

DIAGNOSTIC_TESTUltrasound mesurements

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

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra
Lead SponsorOTHER
County Clinical Emergency Hospital Cluj-Napoca
CollaboratorOTHER
Hospital Ancona
CollaboratorUNKNOWN
Hospital CUF Porto
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Distance from skin to Hyoid bone measured with lineal ultrasound probeImmediately prior to induction of anesthesiaDistance from skin to Hyoid bone measured with lineal ultrasound probe
Distance from skin to epiglottis measured with lineal ultrasound probeImmediately prior to induction of anesthesiaDistance from skin to epiglottis measured with lineal ultrasound probe
Tongue Thickness measured with convex probeImmediately prior to induction of anesthesiaTongue Thickness measured with convex probe
Distance from Jaw to Hyoid bone distance measured with convex probeImmediately prior to induction of anesthesiaDistance from Jaw to Hyoid bone distance measured with convex probe

Secondary

MeasureTime frameDescription
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 anesthesiaModified Mallampati Score
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extendedImmediately prior to induction of anesthesiaThyromental distance
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 closedImmediately prior to induction of anesthesiaSternomental distance
Interincisor distance DIstance in centimeters between fornt incisorsImmediately prior to induction of anesthesiaInterincisor distance
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 lipImmediately prior to induction of anesthesiaUpper Lip Bite Test
neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measuredImmediately prior to induction of anesthesianeck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026