Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai, China
NCT Number: NCT07726641
This study aims to evaluate whether an artificial intelligence-assisted monitoring system can improve the training of novice physicians in electronic nasopharyngolaryngoscopy. The study will compare AI-assisted training with conventional training in terms of post-training examination performance.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Shanghai, China
Electronic nasopharyngolaryngoscopy is an important diagnostic procedure in otorhinolaryngology, but its examination quality is highly dependent on the operator's experience. Novice physicians may have difficulty in systematically visualizing key anatomical regions, maintaining a clear field of view, and completing a standardized examination.
Artificial intelligence-assisted monitoring systems may provide real-time feedback during endoscopic examination and help trainees improve anatomical site recognition and procedural completeness. This study is designed to evaluate the educational value of an AI-assisted monitoring system in the training of novice physicians performing electronic nasopharyngolaryngoscopy.
Novice physicians will be assigned to different training approaches, including an AI-assisted training method and a conventional training method. During the training phase, participants will receive supervised practice, with or without the support of the AI-assisted monitoring system, depending on group allocation.
Following the training period, participants will perform electronic nasopharyngolaryngoscopy under appropriate supervision. Their performance will be evaluated using recorded procedure data and expert assessment to compare outcomes between training approaches. Measures will be taken throughout the study to ensure patient safety under the guidance of experienced physicians.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria for Novice Physicians: Inclusion Criteria
Eligibility Criteria for Patient Participants: Inclusion Criteria
The AI-assisted monitoring system analyzes electronic nasopharyngolaryngoscopy video in real time and provides prompts regarding anatomical sites that have been examined. Examined anatomical sites are displayed on the screen, and the system provides information such as examination time and number of anatomical sites covered. The system is used as an adjunctive training tool and does not replace the clinical judgment of supervising physicians.
Time frame: During each post-training assessment procedure.
Each post-training procedure will be video recorded and assessed by blinded expert raters using Flexible Pharyngo-Laryngoscopy Assessment Tool (FLEXPAT). The scale includes 9 mandatory items, each scored from 1 to 5, with a total score ranging from 9 to 45 points. A higher score indicates better procedural performance.
Time frame: During each post-training assessment procedure.
Time frame: During each post-training assessment procedure.
Time frame: During each post-training assessment procedure.
Image quality will be evaluated by professional raters across two dimensions based on the images captured during the procedure: preservation of anatomical sites and mucosal clarity. Each dimension is scored out of a maximum of 5 points, with a total combined score of 10 points.
Time frame: Immediately after or during each post-training assessment procedure.
Patient comfort will be evaluated based on clinical observation of examination-related discomfort, such as gag reflex, and categorized as good comfort, poor comfort, or very poor comfort.
Time frame: Within 2 weeks after completion of the training phase
Trainees in the AI-assisted training group shall complete a satisfaction questionnaire with a Likert-type scale to assess their experience using the AI-assisted monitoring system. The questionnaire consists of 10 survey items with five rating levels ranging from strongly disagree (1 point) to strongly agree (5 points).
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Application of an Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in the Training of Novice Physicians: A Prospective, Single-Center, Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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