An interventional study of AI smart-glasses intubation practice with automated feedback in Intubation, Intratracheal and Medical Education, sponsored by Tri-Service General Hospital (TSGH). Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Tri-Service General Hospital (TSGH) · Not applicable, Interventional, and Other
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:
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.
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):
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.
Tri-Service General Hospital (TSGH) is the lead sponsor of 38 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rotation 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.
Behavioral: AI smart-glasses intubation practice with automated feedback
Rotation 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.
Behavioral: AI smart-glasses intubation practice with automated feedback
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.
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: End of the 2-week anesthesiology rotation (Week 2, last day)
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.
Time frame: Baseline (Week 1, Day 1) and end of the 2-week rotation (Week 2, last day, after the OSCE)
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.
Time frame: Baseline (Week 1, Day 1) and end of the 2-week rotation (Week 2, last day, after the OSCE)
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.
Time frame: Immediately after the AI smart-glasses practice session (Week 1, Days 2-4 in Arm 1; Week 2, Days 1-4 in Arm 2)
Plan to share: 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.
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 ↗
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Tri-Service General Hospital (TSGH)