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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Nossa Senhora da Conceicao

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged 18 years or older

Patients scheduled for elective non-cardiac surgeries

Disqualifiers

Patients undergoing diagnostic procedures with isolated sedation or local anesthesia

If a patient undergoes more than one surgical intervention during the same hospitalization, only the major procedure will be considered (i.e., additional procedures during the same admission are not eligible for separate inclusion).

Trial design

Treatments tested in this trial

  • AI-based pre-anesthetic assessment
  • Anesthesiologist-led pre-anesthetic evaluation

Treatment groups

No treatment groups listed