Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App LuAna.
- Who it may be relevant to
- Registry conditions: Consolidation, Lung Injury, Pleural Effusion, Pneumothorax. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial
Overview
This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used. The clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.
Detailed description
Imaging diagnostic aid tools that use AI and facilitate the identification of findings on chest x-rays can contribute to doctors' care routines and clinicians' and radiologists' reporting routines, as these tools can allow the organization of care queues according to priorities, in addition to identifying subtle findings on the image, thereby reducing errors in reading the RXT and benefiting patients with greater agility in care and a shorter time until diagnosis. However, for reliability, these tools must undergo rigorous validation processes in large populations before implementation.
Interventions
- Device App LuAna
Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.
Primary outcome measures
- Detection rate [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Non-reported chest X-rays (XRts) of individuals aged over 18 years.
- Individuals images with respiratory complaints.
- Chest X-rays taken during the presence of these respiratory symptoms or while being followed up for respiratory disease.
- Chest X-rays taken on any X-ray machine.
- Chest X-rays that include at least one frontal view of the chest.
Exclusion criteria
- Those whose chest X-ray was performed due to a history of trauma, pre-operative risk assessment, lung cancer screening, or exclusively for verifying the correct positioning of a peripheral intravenous catheter (PICC).
- Chest X-rays with technical quality below the minimum required for proper interpretation and diagnosis.
- Cases without at least one frontal view.
- X-rays printed on regular paper.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Brazil · 1 center
- FEAS Curitiba — Curitiba
Identifiers
NCT: NCT06686251 · LuAna Trial