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Artificial Intelligence-Assisted Training for Novice Physicians in Electronic Nasopharyngolaryngoscopy

21. juli 2026 opdateret af: Ruijin Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

138

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-training procedural performance score
Tidsramme: 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.
During each post-training assessment procedure.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ruijin Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025-802a

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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