Difficult VideolaryngoscopyNCT06925009
Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Unicentric)
An observational study of Difficult Videolaryngoscopy, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. 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
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2023to 1 Jun 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
About this study
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.
Read the detailed description
Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.
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.
The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.
- Conditions
- Difficult Videolaryngoscopy
- Being tested
- Ultrasound mesurements
- Keywords
- Ultrasound;Difficult Videolaryngoscopy; Machine Learning
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
Measured: 5 minutes
Distance from skin to epiglottis measured with lineal ultrasound probe
Measured: 5 minutes
Tongue Thickness measured with convex probe
Measured: 5 minutes
Distance from Jaw to Hyoid bone distance measured with convex probe
Measured: 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.
Measured: 1minute
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended
Measured: 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
Measured: 1minute
Interincisor distance DIstance in centimeters between fornt incisors
Measured: 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
Measured: 1minute
neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured
Measured: 1minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start27 Jan 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925009
- Sponsor's protocol ID
- MAFV 1
- Status last verified
- Jan 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fernandez-Vaquero MA, Oyarzun-Silva R, Hernandez-Hernandez P, Gomez-Rios MA, Petrisor C, Falcetta S, Gomes SH, De Luis-Cabezon N. Airway coach project: development of a machine learning-based model using clinical and ultrasound parameters to support videolaryngoscopy strategy. BMC Anesthesiol. 2026 Jun 18;26(1):456. doi: 10.1186/s12871-026-03943-4.
PubMed 42316024
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 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 (Unicentric)
- ClinicalTrials.gov ID
- NCT06925009
- Acronym / sponsor ID
- MAFV 1
- Conditions
- Difficult Videolaryngoscopy
- Keywords
- Ultrasound;Difficult Videolaryngoscopy; Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Apr 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 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.
Detailed description
Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.
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.
The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.
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: 5 minutes
Distance from skin to epiglottis measured with lineal ultrasound probe
Time frame: 5 minutes
Tongue Thickness measured with convex probe
Time frame: 5 minutes
Distance from Jaw to Hyoid bone distance measured with convex probe
Time frame: 5 minutes
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: 1minute
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended
Time frame: 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
Time frame: 1minute
Interincisor distance DIstance in centimeters between fornt incisors
Time frame: 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
Time frame: 1minute
neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured
Time frame: 1minute
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 2 Jan 2026.
- Derived from this study: PubMed 42316024Fernandez-Vaquero MA, Oyarzun-Silva R, Hernandez-Hernandez P, Gomez-Rios MA, Petrisor C, Falcetta S, Gomes SH, De Luis-Cabezon N. Airway coach project: development of a machine learning-based model using clinical and ultrasound parameters to support videolaryngoscopy strategy. BMC Anesthesiol. 2026 Jun 18;26(1):456. doi: 10.1186/s12871-026-03943-4.
- 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 2 Jan 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: 5 minutes). 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?
On the ClinicalTrials.gov record for NCT06925009, which also lists 1 linked publication.
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 2 Jan 2026.