Application of an Artificial Intelligence-Assisted Monitoring System for Electronic Nasopharyngolaryngoscopy in the Training of Novice Physicians: A Prospective, Single-Center, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Post-training procedural performance score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Post-training procedural performance score
时间窗: 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.
次要结局
- Anatomical Site Coverage Rate(During each post-training assessment procedure.)
- Examination Time(During each post-training assessment procedure.)
- Image Quality Score(During each post-training assessment procedure.)
- Patient Comfort(Immediately after or during each post-training assessment procedure.)
- Trainee Satisfaction with the AI System(Within 2 weeks after completion of the training phase)