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Intubation, IntratrachealNCT07897747

AI Smart Glasses Feedback for Intubation Training in Medical Students

A study testing AI smart-glasses intubation practice with automated feedback in people with Intubation, Intratracheal and Medical Education, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this educational study is to learn whether AI smart glasses can score and give feedback on endotracheal intubation performed by medical students on a manikin, and when this AI feedback is most useful during anesthesia training. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Intubation, Intratracheal, Medical Education
What is being tested?
AI smart-glasses intubation practice with automated feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
1 Jan 2027to 31 Dec 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 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Medical interns (medical students in the clinical internship year) rotating through the Department of Anesthesiology, Tri-Service General Hospital, during the study period
  • Aged 18 years to 30 years old
  • Voluntarily agree to participate and provide written informed consent

Who cannot join

  • Unwilling to participate
  • Previously enrolled in this study during an earlier rotation (no repeat enrollment)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • Tri-Service General Hospital

    Taipei, 114202

Other trials in Taiwan

About this study

Official title: AI Smart Glasses for Automated Scoring and Feedback in Medical Students' Endotracheal Intubation OSCE: A Cluster-Randomized Educational Study

The goal of this educational study is to learn whether AI smart glasses can score and give feedback on endotracheal intubation performed by medical students on a manikin, and when this AI feedback is most useful during anesthesia training. The main questions it aims to answer are:

  • Do AI scores of the intubation OSCE (Objective Structured Clinical Examination) agree with scores given by faculty examiners?
  • Does practicing with AI smart-glasses feedback before or after the airway lecture lead to better intubation OSCE performance, self-efficacy, and cognitive load?

Medical interns rotating through the Department of Anesthesiology at Tri-Service General Hospital (Taiwan) for 2 weeks will be randomized by rotation group to practice intubation once with the AI smart glasses either before the airway lecture (week 1) or after it (week 2). At the end of the rotation, all participants will take an intubation OSCE while wearing the AI glasses, scored independently by a faculty examiner and by the AI. Participants will also complete short questionnaires on self-efficacy (before and after the rotation) and cognitive load (after AI practice). All procedures are performed on a manikin; no patients are involved.

Read the detailed description

Background: Endotracheal intubation is one of the core clinical skills required of medical graduates in Taiwan, but intern pass rates in simulated intubation examinations at our hospital are only about 50-60%. Procedural skill learning depends on timely, specific feedback, yet faculty time is limited. AI smart glasses (HTC) record first-person video of the procedure and use artificial intelligence to score it against a standardized checklist and return immediate item-by-item feedback. The agreement between AI and faculty scoring has not been validated, and the optimal timing of AI feedback relative to formal teaching is unknown.

Design: Prospective, single-center, cluster-randomized (by rotation group, 3-4 interns per group), two-arm parallel educational trial. Rotation groups are allocated 1:1 by computer-generated block randomization.

Procedures (2-week anesthesiology rotation):

  • Week 1, Day 1: informed consent and pre-test questionnaire.
  • Arm 1 (AI before lecture): one AI smart-glasses intubation practice on a manikin during Week 1, Days 2-4, with immediate AI scoring and feedback, followed by a cognitive load questionnaire.
  • Week 1, Day 5: airway lecture (about 1 hour) for all interns.
  • Arm 2 (AI after lecture): one AI smart-glasses practice during Week 2, Days 1-4, with immediate AI scoring and feedback, followed by a cognitive load questionnaire.
  • Last day of Week 2: end-of-rotation intubation OSCE (8 minutes) wearing the AI glasses; a faculty examiner scores the performance in person and the AI scores it independently; post-test questionnaire.

The investigator assisting with the glasses does not teach intubation during practice. OSCE faculty examiners are blinded to group allocation and do not see the AI score before completing their own scoring. Examiners are calibrated before enrollment using at least 10 practice videos.

OSCE checklist: 10 items scored 0/1/2 (total 0-20) plus a global rating scored 1 to 5, pass/fail judgment, and intubation time.

Questionnaires: a 4-item intubation-specific self-efficacy scale adapted from a published smart-glasses intubation training study and a 39-item medical learning self-efficacy questionnaire adapted from a validated multi-dimensional instrument for medical students, both rated on 5-point scales; and a validated 10-item cognitive load questionnaire measuring intrinsic, extraneous, and germane load, rated on a 5-point scale.

Statistical analysis: Agreement between AI and faculty total scores will be assessed with ICC(2,1) (two-way random effects, absolute agreement) with 95% CI and Bland-Altman analysis; item-level agreement with quadratic weighted kappa; pass/fail agreement with Cohen's kappa, sensitivity, and specificity. Between-arm comparisons of OSCE performance, self-efficacy change, and cognitive load will use linear or generalized linear mixed-effects models with rotation group as a random effect, following the intention-to-treat principle.

Sample size: 200 interns (about 100 per arm). With an expected ICC of 0.80, this gives a 95% CI width of no more than 0.10 for the primary agreement analysis; allowing 10% attrition and a design effect of about 1.13, it can detect an effect size of about 0.45 between arms in OSCE total score.

Being tested
AI smart-glasses intubation practice with automated feedback
Keywords
Artificial Intelligence, Smart Glasses, Objective Structured Clinical Examination, Formative Feedback, Simulation Training, Self Efficacy, Cognitive Load

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI smart-glasses intubation practice with automated feedbackBehavioural

    One individual practice session (about 15 minutes) of endotracheal intubation on an airway manikin while wearing AI smart glasses (HTC). The glasses record first-person video of the procedure; after upload, the AI scores the performance against the 10-item intubation OSCE checklist (each item 0/1/2, total 0-20, plus a 1-5 global rating) and immediately displays item-by-item scores and written feedback for the student to review. The investigator only assists with operating the glasses and does not teach intubation during the session. The two arms differ only in the timing of this session relative to the airway lecture.

Study groups in NCT07897747
Study groupRoleWhat they receive
AI Feedback Before Airway LectureExperimentalRotation groups randomized to this arm perform one AI smart-glasses intubation practice session on a manikin with immediate AI scoring and feedback during Week 1, Days 2-4 of the 2-week anesthesiology rotation, before the airway lecture (Week 1, Day 5), followed by a cognitive load questionnaire. All participants complete the end-of-rotation intubation OSCE wearing the AI glasses (scored by faculty and AI) and the self-efficacy questionnaires at the start and end of the rotation.
Receives: Behavioral: AI smart-glasses intubation practice with automated feedback
AI Feedback After Airway LectureActive comparatorRotation groups randomized to this arm attend the airway lecture (Week 1, Day 5) first and then perform one AI smart-glasses intubation practice session on a manikin with immediate AI scoring and feedback during Week 2, Days 1-4 of the 2-week anesthesiology rotation, followed by a cognitive load questionnaire. All participants complete the end-of-rotation intubation OSCE wearing the AI glasses (scored by faculty and AI) and the self-efficacy questionnaires at the start and end of the rotation.
Receives: Behavioral: AI smart-glasses intubation practice with automated feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement Between AI and Faculty Examiner Total Scores on the Intubation OSCE

    Intraclass correlation coefficient ICC(2,1) (two-way random effects, absolute agreement, single rater) with 95% confidence interval between the AI-generated total score and the faculty examiner's total score on the 10-item endotracheal intubation OSCE checklist (each item scored 0, 1, or 2; total score range 0-20, higher scores indicate better performance). Bland-Altman mean difference and 95% limits of agreement will also be reported. The faculty examiner is blinded to group allocation and to the AI score.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

Secondary outcomes (8)
  1. Faculty-Rated Intubation OSCE Total Score

    Total score on the 10-item endotracheal intubation OSCE checklist rated by a faculty examiner blinded to group allocation (each item 0, 1, or 2; range 0-20; higher scores indicate better performance), compared between arms.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

  2. Faculty-Rated Global Performance Rating on the Intubation OSCE

    Faculty examiner's global rating of intubation performance on a 5-point scale (1 = poor, 2 = needs improvement, 3 = fair, 4 = good, 5 = excellent; higher scores indicate better performance), compared between arms.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

  3. Intubation OSCE Pass Rate

    Percentage of participants judged by the faculty examiner to pass the intubation OSCE according to the national graduation competency standard (correct laryngoscope use, correct and appropriate tube placement, and completion of one tube placement within 30 seconds), compared between arms.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

  4. Intubation Time

    Time in seconds from insertion of the laryngoscope blade into the mouth to completion of endotracheal tube placement and removal of the laryngoscope, timed by the faculty examiner during the OSCE, compared between arms.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

  5. Item-Level and Pass/Fail Agreement Between AI and Faculty Examiner

    Agreement between AI and faculty examiner for each of the 10 OSCE checklist items (0/1/2) assessed with quadratic weighted kappa, and for the global rating (scored 1 to 5) assessed with ICC(2,1); agreement on pass/fail assessed with Cohen's kappa, with sensitivity and specificity of the AI pass/fail judgment using the faculty judgment as the reference standard.

    Measured: End of the 2-week anesthesiology rotation (Week 2, last day)

  6. Change in Intubation-Specific Self-Efficacy Score

    Mean score of a 4-item intubation self-efficacy scale adapted from a published smart-glasses intubation training study, each item rated on a 5-point scale (1 = not at all confident, 5 = very confident; range 1-5; higher scores indicate greater self-efficacy). Change from baseline to end of rotation is compared between arms.

    Measured: Baseline (Week 1, Day 1) and end of the 2-week rotation (Week 2, last day, after the OSCE)

  7. Change in Medical Learning Self-Efficacy Score

    Mean score of a 39-item medical learning self-efficacy questionnaire adapted from a validated multi-dimensional medical students' learning self-efficacy questionnaire (subscales: conceptual understanding, practical work, everyday application, higher-order cognitive skills, medical communication, professionalism, and academic self-efficacy), each item rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree; range 1-5; higher scores indicate greater self-efficacy). Change from baseline to end of rotation is compared between arms.

    Measured: Baseline (Week 1, Day 1) and end of the 2-week rotation (Week 2, last day, after the OSCE)

  8. Cognitive Load During AI Smart-Glasses Practice

    Intrinsic (items 1-3), extraneous (items 4-6), and germane (items 7-10) cognitive load subscale mean scores on a validated 10-item cognitive load questionnaire, each item rated on a 5-point scale (1 = not at all applicable, 5 = completely applicable; range 1-5). Higher intrinsic and extraneous scores indicate greater load; higher germane scores indicate greater investment in learning. Compared between arms.

    Measured: Immediately after the AI smart-glasses practice session (Week 1, Days 2-4 in Arm 1; Week 2, Days 1-4 in Arm 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster-randomized, two-arm parallel educational trial. Rotation groups of medical interns (3-4 interns per group, 2-week anesthesiology rotation) are the unit of randomization and are allocated 1:1 to AI smart-glasses practice either before (Arm 1) or after (Arm 2) the airway lecture. All participants take the same end-of-rotation intubation OSCE, scored independently by a faculty examiner and by the AI, which provides the paired data for the AI-faculty agreement analysis.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897747
Sponsor's protocol ID
TSGH-ANES-AIGLASS-2027
Status last verified
Nov 2026
First submitted
20 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data, including first-person procedure videos, will not be shared. The informed consent specifies that study data are accessible only to the principal investigator and authorized co-investigators and that results will be reported only in aggregate. Aggregate results will be published in peer-reviewed journals.

Publications

  • Leppink J, Paas F, Van der Vleuten CP, Van Gog T, Van Merrienboer JJ. Development of an instrument for measuring different types of cognitive load. Behav Res Methods. 2013 Dec;45(4):1058-72. doi: 10.3758/s13428-013-0334-1.

    PubMed 23572251
  • Chao CT, Liang JC. The development and validation of a multi-dimensional medical students' learning self-efficacy questionnaire for clinical education. Med Educ Online. 2025 Dec;30(1):2534053. doi: 10.1080/10872981.2025.2534053. Epub 2025 Jul 20.

    PubMed 40684332
  • Lin YF, Wang CY, Huang YH, Lin SM, Yang YY. Medical students' self-assessed efficacy and satisfaction with training on endotracheal intubation and central venous catheterization with smart glasses in Taiwan: a non-equivalent control-group pre- and post-test study. J Educ Eval Health Prof. 2022;19:25. doi: 10.3352/jeehp.2022.19.25. Epub 2022 Sep 2.

    PubMed 36052556

Questions about this trial

What is this clinical trial studying?

A study testing AI smart-glasses intubation practice with automated feedback in people with Intubation, Intratracheal and Medical Education, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

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 3 inclusion and 2 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 6 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 Taiwan. 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 Wei-Hung Chan, MD (+886-2-87923311 ext. 12546, whcken@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between AI and Faculty Examiner Total Scores on the Intubation OSCE (time frame: End of the 2-week anesthesiology rotation (Week 2, last day)). 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 NCT07897747, which also lists 3 linked publications.

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 6 Nov 2026.

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