Artificial Intelligence-Assisted Training for Novice Physicians in Electronic Nasopharyngolaryngoscopy

Application of an Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in the Training of Novice Physicians: A Prospective, Single-Center, Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Training; Laryngoscopy
• Intervention / Treatment: Device: Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bin Ye, MD PhD; Phone Number: +8615216616895; Email: aydyebin@126.com

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
    • Contact: Bin Ye, MD PhD; Phone Number: +8615216616895; Email: aydyebin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Eligibility Criteria for Novice Physicians： Inclusion Criteria

• Aged 18 years or older.
• Otorhinolaryngology residents or standardized residency training physicians.
• No prior independent experience in electronic nasopharyngolaryngoscopy.
• Holding both a physician qualification certificate and a physician practice certificate registered at the study institution.
• Willing to participate in the study and provide written informed consent. Exclusion Criteria
• Previous participation in other endoscopy training studies.
• Inability to complete the required continuous training period

Eligibility Criteria for Patient Participants： Inclusion Criteria

• Aged 18 years or older.
• Male or female.
• Clinical need for electronic nasopharyngolaryngoscopy.
• Able and willing to provide written informed consent. Exclusion Criteria
• Pregnancy.
• History of allergy to topical anesthetics such as tetracaine or lidocaine.
• Language or communication barriers.
• Anatomical abnormalities, such as laryngeal stenosis, or prior nasopharyngeal or laryngeal surgery.
• Inability to tolerate the examination position.
• Any condition judged by the investigator to make the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Assisted Training Group; Novice physicians in this group will receive additional assistance from an AI-assisted monitoring system during electronic nasopharyngolaryngoscopy training. The AI system provides real-time monitoring and visual prompts for anatomical site coverage during the examination.	Device: Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy; 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.
No Intervention: Conventional Training Group; Novice physicians in this group will receive conventional theoretical and practical training in electronic nasopharyngolaryngoscopy without real-time AI assistance during training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-training procedural performance score	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.	During each post-training assessment procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical Site Coverage Rate		During each post-training assessment procedure.
Examination Time		During each post-training assessment procedure.
Image Quality Score	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.	During each post-training assessment procedure.
Patient Comfort	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.	Immediately after or during each post-training assessment procedure.
Trainee Satisfaction with the AI System	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).	Within 2 weeks after completion of the training phase

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-802a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly. The study involves clinical and endoscopic video data collected from patients, which may contain sensitive medical information. Due to privacy protection, ethical requirements, and institutional data governance policies, de-identified individual participant data will not be made available outside the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No