NCT07459491

Brief Summary

Accurate preoperative risk stratification is essential for perioperative planning, resource allocation, and patient safety. The American Society of Anesthesiologists Physical Status (ASA-PS) classification remains the most widely used global system for assessing preoperative health status. However, ASA classification relies on clinician judgment and may demonstrate inter-observer variability. Recent advances in artificial intelligence (AI), particularly large language models (LLMs), have shown potential for assisting clinical decision-making by synthesizing structured and unstructured medical information. In perioperative medicine, AI systems may support more standardized risk assessment and laboratory testing strategies. The objective of this observational study is to evaluate the agreement between ASA classifications assigned by anesthesiologists and those generated by a large language model (ChatGPT-5) using anonymized preoperative clinical information. The study will also examine differences in laboratory test recommendations and explore the relationship between clinician- and AI-generated risk assessments and perioperative erythrocyte suspension utilization. Adult patients scheduled for elective surgery who undergo routine preoperative anesthesia assessment will be included. For each patient, the ASA classification assigned by the anesthesiologist will be recorded and compared with the classification generated by the AI system using the same anonymized clinical information. This study aims to assess whether AI-assisted preoperative evaluation may support more consistent risk stratification and potentially contribute to more standardized perioperative resource utilization.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
703

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 2, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

artifical intelligencechatgptanesthesiaRisk stratificationPerioperative medicinepreoperative assessmentPerioperative outcomesAgreement analysis

Outcome Measures

Primary Outcomes (1)

  • Agreement Between Anesthesiologist-Assigned and ChatGPT-5-Generated ASA Physical Status Classification

    Agreement between ASA Physical Status classifications assigned by board-certified anesthesiologists and those generated by ChatGPT-5 using anonymized preoperative clinical data. Agreement will be quantified using Cohen's kappa and weighted kappa statistics for ordinal ASA categories (I-V). The comparison will be performed using identical anonymized preoperative clinical summaries.

    At the time of preoperative anesthesia assessment (baseline).

Interventions

This is a non-interventional observational study. No therapeutic or diagnostic intervention is performed as part of the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) scheduled for elective surgery and evaluated at the preoperative anesthesia outpatient clinic of Antalya City Hospital during the study period will constitute the study population. All eligible patients with a completed standardized preoperative anesthesia assessment form and documented ASA Physical Status classification will be considered. Only patients whose clinical data can be fully anonymized and who provide written informed consent will be included. Patients undergoing emergency surgery, pediatric patients, pregnant patients, ASA VI classification, incomplete documentation, or cases with more than 30 days between preoperative assessment and surgery will be excluded.

You may qualify if:

  • Age ≥ 18 years
  • Scheduled for elective surgery
  • Completed standardized preoperative anesthesia evaluation form
  • ASA Physical Status classification assigned by a specialist anesthesiologist
  • Written informed consent
  • Clinical documentation suitable for anonymization

You may not qualify if:

  • Emergency surgery
  • ASA VI classification
  • Pregnancy
  • Pediatric patients (\<18 years)
  • Incomplete or non-standardized clinical documentation
  • Inability to anonymize clinical records
  • More than 30 days between preoperative assessment and surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya City Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Damla Kaytancı Özçelik

    Antalya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
specialist in anaesthesiology and reanimation, Principal Investigator

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 9, 2026

Study Start

January 10, 2026

Primary Completion

February 10, 2026

Study Completion

May 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations