Airway UltrasoundALUDANCT07910071
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
A study testing Airway Ultrasound Education and Supervised Training in people with Airway Ultrasound and Difficult Airway Management, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
This study aims to determine how many supervised practice attempts anesthesia trainees need to become competent in using ultrasound to assess the airway. Airway ultrasound may help clinicians identify anatomical features associated with a difficult airway, which can make breathing support or placement of a breathing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Ultrasound, Difficult Airway Management, Airway Ultrasonography
- What is being tested?
- Airway Ultrasound Education and Supervised Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2026to 15 Nov 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers:
- Healthy adult volunteers
- Older than 18 years old
- Trainees:
- Healthy adult Mount Sinai clinical fellows or residents
- Older than 18 years old
Who cannot join
- Volunteers:
- -Patients
- Trainees:
- -Previous knowledge of airway ultrasound for diffi-cult airways
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Department of Anesthesia Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Naveed Siddiqui, MD, 416-586-4800 ext. 5270, naveed.siddiqui@uhn.on.ca
Kong E You-Ten, MD, PhD
About this study
Official title: Anesthesiologists' Learning Curves in Ultrasound As-sessment of Difficult Airway (ALUDA)
This study aims to determine how many supervised practice attempts anesthesia trainees need to become competent in using ultrasound to assess the airway. Airway ultrasound may help clinicians identify anatomical features associated with a difficult airway, which can make breathing support or placement of a breathing tube more challenging during anesthesia. However, the amount of training needed to perform these ultrasound measurements accurately has not been established.
Eight anesthesia trainees will receive theoretical instruction and hands-on training before performing ultrasound assessments on 20 healthy adult volunteers. The trainees will measure tongue thickness and the distances from the skin to the epiglottis and vocal cords. Their measurements will be compared with those of experienced airway ultrasound experts to assess accuracy and determine how many attempts are needed to achieve competency. A follow-up assessment three months later will evaluate whether the trainees retain their skills.
The study hypothesis is that anesthesia trainees can achieve competency in airway ultrasound assessment after a limited number of supervised practice attempts and retain these skills over time. The findings may help establish evidence-based training requirements for airway ultrasound assessment.
Read the detailed description
Airway management is an essential component of anesthesia, and unexpected difficulty with ventilation or placement of a breathing tube can lead to serious complications. Traditional clinical assessments do not always reliably identify patients who may have a difficult airway. Point-of-care ultrasound offers a non-invasive method of assessing airway anatomy and measuring features associated with difficult airway management. However, the number of supervised ultrasound assessments required for anesthesia trainees to achieve competency in these measurements has not been established.
The Anesthesiologists' Learning curves in Ultrasound assessment of Difficult Airway (ALUDA) study is a prospective educational cohort study that will evaluate the learning curves of anesthesia trainees performing ultrasound assessments of the airway. The study will take place at Mount Sinai Hospital in Toronto, Canada, and aims to enroll eight anesthesia residents or fellows and 20 healthy adult volunteers. No patients will be recruited or undergo study procedures.
Anesthesia trainees will receive theoretical instruction followed by a hands-on ultrasound workshop under the direct supervision of experienced airway ultrasound clinicians. Each trainee will perform 20 quantitative ultrasound assessments on healthy volunteers, measuring tongue thickness, the distance from the skin to the epiglottis, and the distance from the skin to the vocal cords. Each measurement attempt will take a maximum of five minutes, with a maximum of 120 minutes per trainee, including feedback. Measurements will be compared with expert reference measurements.
The primary objective is to determine the number of attempts required for trainees to achieve competency in each ultrasound measurement. A measurement will be considered successful when it is within 20% above or below the expert reference measurement and falls on the same side of the established cutoff used to predict airway difficulty. Individual learning curves will be evaluated using the cumulative sum (CUSUM) method, a statistical approach that tracks performance across consecutive attempts to identify when a predefined competency standard has been reached.
Secondary objectives include assessing the average difference between trainee and expert measurements, the overall and measurement-specific success rates, the time required to complete each measurement, and retention of ultrasound skills three months after the initial training session. At the three-month follow-up, trainees will repeat the ultrasound assessments to evaluate whether their measurement accuracy and skills have been maintained.
The study hypothesizes that anesthesia trainees can achieve competency in ultrasound assessment of airway anatomy after a limited number of supervised practice attempts and retain these skills over time. The results may help establish evidence-based training requirements and inform the development of standardized educational approaches for airway ultrasound assessment.
- Conditions
- Airway Ultrasound, Difficult Airway Management, Airway Ultrasonography, Medical Education, Anesthesia Training
- Being tested
- Airway Ultrasound Education and Supervised Training
- Keywords
- Airway ultrasonography, Point-of-care ultrasound, Anesthesia education, Learning curve, CUSUM, Cumulative sum analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Ultrasound Education and Supervised TrainingBehavioural
The intervention consists of theoretical instruction and a supervised hands-on workshop in airway point-of-care ultrasound for anesthesia residents or fellows. Following training, each trainee will perform 20 quantitative airway ultrasound assessments on healthy adult volunteers. The measurements will include tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. Each measurement attempt will take a maximum of five minutes, with a maximum of 120 minutes per trainee, including feedback. Trainee measurements will be compared with expert reference measurements to assess accuracy and determine the number of attempts required to achieve competency. A follow-up assessment at three months will evaluate retention of ultrasound measurement skills.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia Trainees Receiving Airway Ultrasound Training | Experimental | Anesthesia trainees will receive theoretical instruction and supervised hands-on training in airway point-of-care ultrasound. Each trainee will perform 20 quantitative airway ultrasound assessments on healthy adult volunteers, measuring tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. Trainee measurements will be compared with expert reference measurements to evaluate accuracy and determine the number of attempts required to achieve competency. A follow-up assessment at three months will evaluate retention of ultrasound measurement skills. Receives: Behavioral: Airway Ultrasound Education and Supervised Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts required to achieve competency in the CUSUM learning curves for each airway ultrasound measurement
The number of attempts required for trainees to achieve competency in the CUSUM learning curves for each airway ultrasound measurement. A successful measurement is defined by meeting both of the following criteria: (1) the trainee's measurement is within ±20% of the expert reference measurement; and (2) the trainee's measurement and the expert reference measurement are on the same side of the cutoff point for predicting airway difficulty. Competency is determined when the CUSUM score crosses the two downward decision lines.
Measured: 3 months
Secondary outcomes (4)
To assess the mean difference between the benchmark expert measurements and the trainee measurements
The mean difference between benchmark expert measurements and trainee measurements for each airway ultrasound parameter: tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. This outcome will assess the accuracy of trainee measurements compared with expert reference measurements.
Measured: 3 months
To assess the overall success rate and the success rate for each measurement
The overall success rate across all trainee airway ultrasound measurement attempts and the success rate for each individual measurement: tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. A successful measurement is defined as one that is within ±20% of the expert reference measurement and is on the same side of the cutoff point for predicting airway difficulty.
Measured: During the initial training session.
To assess the duration of US measurements
The duration of each airway ultrasound measurement, measured from initial ultrasound probe placement to the recording of the measurement. This outcome will assess the time required for trainees to perform each airway ultrasound measurement.
Measured: During the initial training session.
To assess the 3-month skill retention for correct US measurements
The proportion of correct airway ultrasound measurements performed by trainees at the three-month follow-up assessment, evaluating retention of measurement skills following the initial training session. Correct measurements will be assessed using the study-defined criteria for a successful measurement: within ±20% of the expert reference measurement and on the same side of the cutoff point for predicting airway difficulty.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway UltrasoundStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910071
- Sponsor's protocol ID
- 1551
- Acronym
- ALUDA
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiologists' Learning Curves in Ultrasound As-sessment of Difficult Airway (ALUDA)
- ClinicalTrials.gov ID
- NCT07910071
- Acronym / sponsor ID
- ALUDA / 1551
- Conditions
- Airway Ultrasound, Difficult Airway Management, Airway Ultrasonography, Medical Education, Anesthesia Training
- Keywords
- Airway ultrasonography, Point-of-care ultrasound, Anesthesia education, Learning curve, CUSUM, Cumulative sum analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Collaborators
- Sinai Health System
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 2 Nov 2026 (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 study aims to determine how many supervised practice attempts anesthesia trainees need to become competent in using ultrasound to assess the airway. Airway ultrasound may help clinicians identify anatomical features associated with a difficult airway, which can make breathing support or placement of a breathing tube more challenging during anesthesia. However, the amount of training needed to perform these ultrasound measurements accurately has not been established.
Eight anesthesia trainees will receive theoretical instruction and hands-on training before performing ultrasound assessments on 20 healthy adult volunteers. The trainees will measure tongue thickness and the distances from the skin to the epiglottis and vocal cords. Their measurements will be compared with those of experienced airway ultrasound experts to assess accuracy and determine how many attempts are needed to achieve competency. A follow-up assessment three months later will evaluate whether the trainees retain their skills.
The study hypothesis is that anesthesia trainees can achieve competency in airway ultrasound assessment after a limited number of supervised practice attempts and retain these skills over time. The findings may help establish evidence-based training requirements for airway ultrasound assessment.
Detailed description
Airway management is an essential component of anesthesia, and unexpected difficulty with ventilation or placement of a breathing tube can lead to serious complications. Traditional clinical assessments do not always reliably identify patients who may have a difficult airway. Point-of-care ultrasound offers a non-invasive method of assessing airway anatomy and measuring features associated with difficult airway management. However, the number of supervised ultrasound assessments required for anesthesia trainees to achieve competency in these measurements has not been established.
The Anesthesiologists' Learning curves in Ultrasound assessment of Difficult Airway (ALUDA) study is a prospective educational cohort study that will evaluate the learning curves of anesthesia trainees performing ultrasound assessments of the airway. The study will take place at Mount Sinai Hospital in Toronto, Canada, and aims to enroll eight anesthesia residents or fellows and 20 healthy adult volunteers. No patients will be recruited or undergo study procedures.
Anesthesia trainees will receive theoretical instruction followed by a hands-on ultrasound workshop under the direct supervision of experienced airway ultrasound clinicians. Each trainee will perform 20 quantitative ultrasound assessments on healthy volunteers, measuring tongue thickness, the distance from the skin to the epiglottis, and the distance from the skin to the vocal cords. Each measurement attempt will take a maximum of five minutes, with a maximum of 120 minutes per trainee, including feedback. Measurements will be compared with expert reference measurements.
The primary objective is to determine the number of attempts required for trainees to achieve competency in each ultrasound measurement. A measurement will be considered successful when it is within 20% above or below the expert reference measurement and falls on the same side of the established cutoff used to predict airway difficulty. Individual learning curves will be evaluated using the cumulative sum (CUSUM) method, a statistical approach that tracks performance across consecutive attempts to identify when a predefined competency standard has been reached.
Secondary objectives include assessing the average difference between trainee and expert measurements, the overall and measurement-specific success rates, the time required to complete each measurement, and retention of ultrasound skills three months after the initial training session. At the three-month follow-up, trainees will repeat the ultrasound assessments to evaluate whether their measurement accuracy and skills have been maintained.
The study hypothesizes that anesthesia trainees can achieve competency in ultrasound assessment of airway anatomy after a limited number of supervised practice attempts and retain these skills over time. The results may help establish evidence-based training requirements and inform the development of standardized educational approaches for airway ultrasound assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia Trainees Receiving Airway Ultrasound Training | Experimental | Behavioral: Airway Ultrasound Education and Supervised TrainingAnesthesia trainees will receive theoretical instruction and supervised hands-on training in airway point-of-care ultrasound. Each trainee will perform 20 quantitative airway ultrasound assessments on healthy adult volunteers, measuring tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. Trainee measurements will be compared with expert reference measurements to evaluate accuracy and determine the number of attempts required to achieve competency. A follow-up assessment at three months will evaluate retention of ultrasound measurement skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers
- Older than 18 years old
- Healthy adult Mount Sinai clinical fellows or residents
- Older than 18 years old
Key exclusion criteria (4 listed)
- -Patients
- -Previous knowledge of airway ultrasound for diffi-cult airways
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 |
|---|---|---|
| Airway Ultrasound Education and Supervised TrainingThe intervention consists of theoretical instruction and a supervised hands-on workshop in airway point-of-care ultrasound for anesthesia residents or fellows. Following training, each trainee will perform 20 quantitative airway ultrasound assessments on healthy adult volunteers. The measurements will include tongue thickness, skin-to-epiglottis distance, and skin-to-vocal-cords distance. Each measurement attempt will take a maximum of five minutes, with a maximum of 120 minutes per trainee, including feedback. Trainee measurements will be compared with expert reference measurements to assess accuracy and determine the number of attempts required to achieve competency. A follow-up assessment at three months will evaluate retention of ultrasound measurement skills. | Behavioural | Anesthesia Trainees Receiving Airway Ultrasound Training |
Primary outcome
Number of attempts required to achieve competency in the CUSUM learning curves for each airway ultrasound measurement
Time frame: 3 months
The number of attempts required for trainees to achieve competency in the CUSUM learning curves for each airway ultrasound measurement. A successful measurement is defined by meeting both of the following criteria: (1) the trainee's measurement is within ±20% of the expert reference measurement; and (2) the trainee's measurement and the expert reference measurement are on the same side of the cutoff point for predicting airway difficulty. Competency is determined when the CUSUM score crosses the two downward decision lines.
4 secondary outcomes
To assess the mean difference between the benchmark expert measurements and the trainee measurements
Time frame: 3 months
To assess the overall success rate and the success rate for each measurement
Time frame: During the initial training session.
To assess the duration of US measurements
Time frame: During the initial training session.
To assess the 3-month skill retention for correct US measurements
Time frame: 3 months
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 Nov 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Airway Ultrasound Education and Supervised Training in people with Airway Ultrasound and Difficult Airway Management, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Nov 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 Canada. 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?
Contact Kong E You-Ten, MD, PhD (416-586-4800 ext. 5270, Eric.You-Ten@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempts required to achieve competency in the CUSUM learning curves for each airway ultrasound measurement (time frame: 3 months). 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 2 Nov 2026.