NCT07399938

Brief Summary

The American Society of Anesthesiologists (ASA) Physical Status Classification System is widely used to assess perioperative risk, but it does not explicitly include frailty as a standardized variable. In daily clinical practice, anesthesiologists may implicitly incorporate frailty-related information into ASA classification based on individual clinical judgment, which may lead to variability between evaluators. In recent years, large language models (LLMs), a type of artificial intelligence, have been increasingly used in medical decision-support research. Unlike human clinicians, these models process information in a structured and explicit manner, without relying on intuition or implicit reasoning. The primary objective of this study is to compare ASA Physical Status classifications assigned by anesthesiologists and by two different large language models using standardized preoperative clinical data from adult patients undergoing elective surgery. A secondary objective is to evaluate how the addition of a frailty index influences ASA classification decisions made by human experts and artificial intelligence models. This prospective observational study aims to improve understanding of differences in clinical reasoning between anesthesiologists and artificial intelligence systems and to explore the role of frailty in perioperative risk assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 29, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

January 29, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

ASA Physical Status ClassificationArtificial IntelligenceLarge Language ModelsAnesthesiologyFrailtyPreoperative AssessmentClinical Decision SupportInterrater AgreementKappa Statistics

Outcome Measures

Primary Outcomes (1)

  • Interrater Agreement in ASA Physical Status Classification Between Anesthesiologists and Large Language Models

    Agreement in ASA Physical Status Classification (ASA I-V) between four anesthesiologists and two large language models based on standardized preoperative clinical data, assessed using interrater agreement statistics.

    At the time of preoperative evaluation, prior to surgery

Secondary Outcomes (3)

  • Effect of Frailty Information on ASA Physical Status Classification

    At the time of preoperative evaluation, prior to surgery

  • Agreement Between Large Language Models in ASA Physical Status Classification

    At the time of preoperative evaluation, prior to surgery

  • Agreement Among Anesthesiologists in ASA Physical Status Classification

    At the time of preoperative evaluation, prior to surgery

Study Arms (1)

Adult Elective Surgery Patients

Adult patients aged 18 years and older scheduled for elective surgical procedures. Standardized preoperative clinical data will be evaluated by anesthesiologists and large language models for ASA Physical Status Classification, with and without the addition of frailty information.

Other: Observational Assessment Only

Interventions

This is an observational study with no clinical intervention. No treatment, procedure, drug, or device is assigned as part of the study. ASA Physical Status Classification is assessed using existing preoperative clinical data.

Adult Elective Surgery Patients

Eligibility Criteria

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

Adult patients undergoing elective surgical procedures whose standardized preoperative clinical data are evaluated for ASA Physical Status Classification by anesthesiologists and large language models.

You may qualify if:

  • Adult patients aged 18 years and older
  • Scheduled for elective surgical procedures

You may not qualify if:

  • Emergency surgical procedures
  • Pediatric patients
  • Patients with insufficient or incomplete clinical data preventing ASA Physical --Status assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • cansu ofluoglu, MD

    ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 10, 2026

Study Start

February 25, 2026

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations