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Prospective Validation of an Artificial Intelligence Tool for Pre-Anesthetic Assessment

NCT07290647 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2025-12-18

No results posted yet for this study

Summary

This prospective observational cohort study aims to validate an artificial intelligence (AI) tool designed for pre-anesthetic assessment in Portuguese, tailored to the Brazilian healthcare context. Conducted at a single tertiary hospital, the study will enroll 270 adult patients (aged \>18 years) scheduled for elective non-cardiac surgeries. Participants will use the AI tool to complete a self-assessment, generating general patient guidance and a detailed medical evaluation (the latter withheld from the anesthesiologist). A standard pre-anesthetic evaluation will then be performed by an anesthesiologist blinded to the AI results. A third blinded anesthesiologist will compare the assessments for accuracy, consistency, and risk identification (e.g., ASA classification and perioperative risk models). Primary outcome is concordance between AI and human assessments using Cohen's Kappa. Secondary outcomes include anesthesiologist perceptions of the tool's utility, impact on assessment quality, and patient usability challenges. The study poses minimal risks, with data collected over 24 months, and aims to enhance perioperative safety and efficiency in Brazil.

Conditions

  • Preoperative Care

Interventions

OTHER

AI-based pre-anesthetic assessment

Patients use an artificial intelligence (AI) tool based on a Large Language Model (LLM) in Portuguese to complete a pre-anesthetic self-assessment. The tool collects patient information and generates two outputs: Generic Orientations: General instructions sent directly to the patient to aid in surgical preparation. Specific Assessment: A detailed evaluation, including recommendations and warning signs for medical use, which is not shared with the anesthesiologist performing the traditional evaluation.

OTHER

Anesthesiologist-led pre-anesthetic evaluation

Each patient undergoes a standard pre-anesthetic evaluation conducted by an anesthesiologist, following routine clinical practice at both institutions. This evaluation is performed without access to the AI tool's results to ensure blinding. Purpose: To serve as the comparator for the AI-based assessment, allowing evaluation of concordance in risk assessment, quality of information collected, and clinical judgment. Details: The anesthesiologist conducts a clinical interview and review of medical records, assessing factors such as the American Society of Anesthesiologists (ASA) classification, perioperative risk models (for instance, Ex-Care model), and potential complications.

Sponsors & Collaborators

  • Hospital Nossa Senhora da Conceicao

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290647 on ClinicalTrials.gov