Difficult VideolaryngoscopyNCT06881589
Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Multicentric)
An observational study of Difficult Videolaryngoscopy, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Difficult Videolaryngoscopy
- What is being tested?
- Ultrasound mesurements
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clinica Universidad de Navarra
Madrid, Madrid, 28027
Miguel Angel Fernandez-Vaquero, MD, PhD, +34913531920 ext. 7633, mfvaquero@unav.es
Cristina Petrisor, MD
About this study
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.
- Conditions
- Difficult Videolaryngoscopy
- Being tested
- Ultrasound mesurements
- Keywords
- Ultrasound;, AI analyses, Difficult Videolaryngoscopy,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound mesurementsDiagnostic test
Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasound mesurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance from skin to Hyoid bone measured with lineal ultrasound probe
Distance from skin to Hyoid bone measured with lineal ultrasound probe
Measured: 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
Measured: Immediately prior to induction of anesthesia
Tongue Thickness measured with convex probe
Tongue Thickness measured with convex probe
Measured: 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
Measured: 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.
Modified Mallampati Score
Measured: Immediately prior to induction of anesthesia
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended
Thyromental distance
Measured: 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
Sternomental distance
Measured: Immediately prior to induction of anesthesia
Interincisor distance DIstance in centimeters between fornt incisors
Interincisor distance
Measured: 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
Upper Lip Bite Test
Measured: Immediately prior to induction of anesthesia
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
Measured: Immediately prior to induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start27 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult VideolaryngoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- County Clinical Emergency Hospital Cluj-Napoca, Hospital Ancona, Hospital CUF Porto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881589
- Sponsor's protocol ID
- MAFV 2
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Multicentric)
- ClinicalTrials.gov ID
- NCT06881589
- Acronym / sponsor ID
- MAFV 2
- Conditions
- Difficult Videolaryngoscopy
- Keywords
- Ultrasound;, AI analyses, Difficult Videolaryngoscopy,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- County Clinical Emergency Hospital Cluj-Napoca, Hospital Ancona, Hospital CUF Porto
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing general anesthesia with videolaryngoscopy intubation | – | Diagnostic Test: Ultrasound mesurementsPatient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound mesurementsCompare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation. | Diagnostic test | Patient undergoing general anesthesia with videolaryngoscopy intubation |
Primary outcome
Distance from skin to Hyoid bone measured with lineal ultrasound probe
Time frame: Immediately prior to induction of anesthesia
Distance from skin to Hyoid bone measured with lineal ultrasound probe
Distance from skin to epiglottis measured with lineal ultrasound probe
Time frame: Immediately prior to induction of anesthesia
Distance from skin to epiglottis measured with lineal ultrasound probe
Tongue Thickness measured with convex probe
Time frame: Immediately prior to induction of anesthesia
Tongue Thickness measured with convex probe
Distance from Jaw to Hyoid bone distance measured with convex probe
Time frame: Immediately prior to induction of anesthesia
Distance from Jaw to Hyoid bone distance measured with convex probe
6 secondary outcomes
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.
Time frame: Immediately prior to induction of anesthesia
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended
Time frame: 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
Time frame: Immediately prior to induction of anesthesia
Interincisor distance DIstance in centimeters between fornt incisors
Time frame: 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
Time frame: Immediately prior to induction of anesthesia
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Videolaryngoscopy, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance from skin to Hyoid bone measured with lineal ultrasound probe (time frame: Immediately prior to induction of anesthesia). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.