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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bin Ye, MD PhD
- 전화번호: +8615216616895
- 이메일: aydyebin@126.com
연구 장소
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Shanghai, 중국
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
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연락하다:
- Bin Ye, MD PhD
- 전화번호: +8615216616895
- 이메일: aydyebin@126.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Post-training procedural performance score
기간: During each post-training assessment procedure.
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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.
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During each post-training assessment procedure.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anatomical Site Coverage Rate
기간: During each post-training assessment procedure.
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During each post-training assessment procedure.
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Examination Time
기간: During each post-training assessment procedure.
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During each post-training assessment procedure.
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Image Quality Score
기간: During each post-training assessment procedure.
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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.
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During each post-training assessment procedure.
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Patient Comfort
기간: Immediately after or during each post-training assessment procedure.
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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.
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Immediately after or during each post-training assessment procedure.
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Trainee Satisfaction with the AI System
기간: Within 2 weeks after completion of the training phase
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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).
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Within 2 weeks after completion of the training phase
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-802a
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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