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Artificial Intelligence Versus Anesthesiology Residents in Chest X-Ray Interpretation

23 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

35

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Çiğdem Ünal Kantekin, MD
  • Numero di telefono: +90 505 443 30 56
  • Email: drcgdm@hotmail.com

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: OTHER
  • Prospettive temporali: CROSS_SECTIONAL

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Accuracy for Detection of Thoracic Abnormalities
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sensitivity for Detection of Thoracic Abnormalities
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Çiğdem Ünal Kantekin, MD, Kayseri City Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 ottobre 2026

Completamento primario (Stimato)

15 novembre 2026

Completamento dello studio (Stimato)

15 novembre 2026

Date di iscrizione allo studio

Primo inviato

23 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2026

Primo Inserito (Effettivo)

29 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KCH-PAAG-AI-2026-1081

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .