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Not yet recruitingNCT07910071ALUDAUpdated Nov 2, 2026

Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway

An interventional study of Airway Ultrasound Education and Supervised Training in Airway Ultrasound, Difficult Airway Management and Airway Ultrasonography, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Basic science

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 138 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

Volunteers:

  • Inclusion Criteria:
  • Healthy adult volunteers
  • Older than 18 years old

Trainees:

  • Healthy adult Mount Sinai clinical fellows or residents
  • Older than 18 years old

Exclusion Criteria:

Volunteers:

-Patients

Trainees:

-Previous knowledge of airway ultrasound for diffi-cult airways

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Anesthesia Trainees Receiving Airway Ultrasound Training

    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.

    Behavioral: Airway Ultrasound Education and Supervised Training

Interventions

  • BehavioralAirway Ultrasound Education and Supervised Training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: During the initial training session.

  3. 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.

    Time frame: During the initial training session.

  4. 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.

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07910071
Collaborators
Sinai Health System
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 15, 2028 (estimated)
Completion
Nov 15, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Kong E You-Ten, MD, PhD
Contact
Eric.You-Ten@sinaihealth.ca
416-586-4800 ext. 5270

Oversight

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

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