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Artificial Intelligence Versus Anesthesiology Residents in Chest X-Ray Interpretation

23 de septiembre de 2026 actualizado por: Çiğdem Ünal Kantekin

Comparison of the Diagnostic Performance of an Artificial Intelligence System and Anesthesiology Residents in Interpreting Posteroanterior Chest Radiographs

This observational study will compare how accurately anesthesiology residents and an artificial intelligence system (hChestXR) identify abnormalities on chest X-rays. Approximately 35 volunteer anesthesiology residents at Kayseri City Hospital will review the same set of 150 anonymized posteroanterior chest radiographs selected from the hospital imaging archive. The set will include normal images and images showing findings such as infiltration, atelectasis, and pleural effusion. Two radiologists will independently assess the images and resolve disagreements by consensus to establish the reference standard. Residents will not see the radiologists' assessments or the artificial intelligence results while interpreting the images. The study will measure diagnostic accuracy and other measures of diagnostic performance. No additional imaging, treatment, or change in patient care is planned.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

This single-center, cross-sectional, observational diagnostic accuracy study will be coordinated by the Department of Anesthesiology and Reanimation at Kayseri City Hospital. Volunteer resident assessments will be collected prospectively using retrospectively selected chest radiographs. The observational model is classified as Other because this is a comparative multi-reader, multi-case assessment of a fixed image set, without longitudinal follow-up.

A dataset of 150 posteroanterior chest radiographs will be selected from the hospital PACS to represent normal findings, common thoracic abnormalities, and a limited number of atypical or diagnostically challenging cases. The distribution of findings will be balanced to avoid marked overrepresentation or underrepresentation of particular abnormalities. All patient-identifying information will be removed before assessment.

Two radiologists will independently evaluate each radiograph. Disagreements will be resolved through joint review and consensus. Their final assessments will serve as the reference standard. The same radiographs will be analyzed by the hChestXR artificial intelligence system and independently interpreted by approximately 35 anesthesiology residents who provide informed consent. Residents will record suspected findings using a predefined multiple-choice assessment form and will be blinded to the radiologist and artificial intelligence assessments. Resident training year will also be recorded.

Diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated overall and by finding. Comparisons between resident and hChestXR performance will account for the paired image assessments and the multi-reader, multi-case structure of the data. McNemar testing will be used for appropriate paired comparisons, and analyses will account for variability across readers and radiographs. Agreement with the radiologist reference standard will be evaluated using Cohen's kappa. A multi-reader, multi-case approach will consider individual resident performance and variability across readers interpreting the same image set. Analyses will use SPSS version 31.0, with p < 0.05 considered statistically significant.

An a priori sample size calculation was performed to determine the number of resident readers. Assuming an absolute difference of 15 percentage points in diagnostic accuracy between anesthesiology residents and hChestXR, a standard deviation of 25 percentage points in reader-level accuracy, a two-sided significance level of 0.05, and 90% power, the required minimum sample size was 32 residents (standardized effect size, Cohen's d = 0.60). To allow for incomplete assessments or participant withdrawal, at least 35 anesthesiology residents are planned for enrollment. The 150 radiographs constitute the image dataset and are distinct from the enrolled resident participants.

The study involves no patient intervention. Resident assessment data will be coded and de-identified for analysis, and identifying information will remain confidential. The planned study period is October 15, 2026, through November 15, 2026. Ethics approval was granted by the Kayseri City Hospital Non-Interventional Clinical Research Ethics Committee on August 26, 2026 (decision number 1081).

Tipo de estudio

De observación

Inscripción (Estimado)

35

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Çiğdem Ünal Kantekin, MD
  • Número de teléfono: +90 505 443 30 56
  • Correo electrónico: drcgdm@hotmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Kayseri, Turquía (Türkiye), 38080
        • Kayseri City Hospital
        • Contacto:
          • Çiğdem Ünal Kantekin, MD
          • Número de teléfono: +90 505 443 30 56
          • Correo electrónico: drcgdm@hotmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Approximately 35 adult anesthesiology and reanimation residents working at Kayseri City Hospital who volunteer and provide written informed consent. Enrollment refers to resident readers, not to the 150 retrospectively selected, anonymized chest radiographs used as the assessment dataset.

Descripción

Inclusion Criteria:

  • An anesthesiology and reanimation resident working at Kayseri City Hospital.
  • Voluntarily agrees to participate in the study.
  • Provides written informed consent.
  • Agrees to evaluate the posteroanterior chest radiographs presented in the study.

Exclusion Criteria:

  • Failure to complete the 150-radiograph assessment.
  • Withdrawal of consent before completion of the assessment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: OTHER
  • Perspectivas temporales: CROSS_SECTIONAL

Cohortes e Intervenciones

Grupo / Cohorte
Anesthesiology Residents

Approximately 35 volunteer anesthesiology and reanimation residents at Kayseri City Hospital will independently interpret 150 anonymized posteroanterior chest radiographs using a predefined multiple-choice form. Residents will be blinded to radiologist assessments and hChestXR outputs. Their diagnostic performance will be compared with hChestXR analysis of the same images, using the consensus of two radiologists as the reference standard. The artificial intelligence system is an image-level comparator, not a separate participant cohort. No treatment is assigned and no patient care is changed.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diagnostic Accuracy for Detection of Thoracic Abnormalities
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Percentage of correctly classified image-finding pairs, calculated as (true positives + true negatives) / all evaluated image-finding classifications × 100, using the consensus of two radiologists as the reference standard. Accuracy will be calculated for each resident and for hChestXR overall and separately for each predefined thoracic finding.

During completion of the 150-radiograph assessment, within the 1-month study period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sensitivity for Detection of Thoracic Abnormalities
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Percentage of reference-positive classifications correctly identified: true positives / (true positives + false negatives) × 100. Sensitivity will be calculated for residents and hChestXR overall and by finding, using the consensus of two radiologists as the reference standard.

During completion of the 150-radiograph assessment, within the 1-month study period
Specificity for Detection of Thoracic Abnormalities
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Percentage of reference-negative classifications correctly identified: true negatives / (true negatives + false positives) × 100. Specificity will be calculated for residents and hChestXR overall and by finding, using the consensus of two radiologists as the reference standard.

During completion of the 150-radiograph assessment, within the 1-month study period
Positive Predictive Value
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Percentage of positive classifications confirmed by the radiologist reference standard: true positives / (true positives + false positives) × 100. Calculated for residents and hChestXR overall and by finding within the constructed study dataset.

During completion of the 150-radiograph assessment, within the 1-month study period
Negative Predictive Value
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Percentage of negative classifications confirmed by the radiologist reference standard: true negatives / (true negatives + false negatives) × 100. Calculated for residents and hChestXR overall and by finding within the constructed study dataset.

During completion of the 150-radiograph assessment, within the 1-month study period
Agreement With the Radiologist Reference Standard
Periodo de tiempo: During completion of the 150-radiograph assessment, within the 1-month study period

Agreement of resident interpretations and hChestXR classifications with the consensus radiologist reference standard will be assessed using Cohen's kappa. Cohen's kappa will be calculated separately for each resident and for hChestXR, with resident results summarized across readers. Kappa ranges from -1 to 1; 1 indicates perfect agreement, 0 agreement expected by chance, and negative values less agreement than expected by chance. Individual reader results will be evaluated within the multi-reader, multi-case framework.

During completion of the 150-radiograph assessment, within the 1-month study period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Çiğdem Ünal Kantekin, MD, Kayseri City Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de octubre de 2026

Finalización primaria (Estimado)

15 de noviembre de 2026

Finalización del estudio (Estimado)

15 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Publicado por primera vez (Actual)

29 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • KCH-PAAG-AI-2026-1081

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared with third parties, in accordance with the confidentiality provisions of the study protocol. Data will be used for scientific analyses, and findings will be disseminated in aggregate through presentations and publications.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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