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Artificial Intelligence-Assisted Training for Novice Physicians in Electronic Nasopharyngolaryngoscopy

21. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

138

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-training procedural performance score
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anatomical Site Coverage Rate
Zeitfenster: During each post-training assessment procedure.
During each post-training assessment procedure.
Examination Time
Zeitfenster: During each post-training assessment procedure.
During each post-training assessment procedure.
Image Quality Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ruijin Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

28. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2025-802a

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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