NCT07364942

Brief Summary

Preoperative evaluation is essential for identifying patient-related risks before elective surgery and for planning safe anesthesia management. Traditionally, this evaluation is performed by anesthesiologists based on clinical history, physical examination, comorbidities, and laboratory findings. This observational study aims to compare the clinical performance of a machine learning-based artificial intelligence system with anesthesiologist assessment during preoperative patient evaluation. The artificial intelligence system independently analyzes patient data and generates risk assessments, which are then compared with evaluations performed by anesthesiologists. The primary objective of the study is to assess the level of agreement between the artificial intelligence system and anesthesiologists in preoperative risk assessment. Secondary objectives include evaluating the accuracy and consistency of the artificial intelligence system and exploring its potential role as a decision-support tool in preoperative clinical practice. The findings of this study may contribute to understanding the potential benefits and limitations of artificial intelligence-assisted decision making in preoperative evaluation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 10, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

Preoperative assessment,Artificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Rate of Agreement Between Artificial Intelligence-Based and Anesthesiologist Preoperative Risk Assessments

    This outcome measures the level of agreement between an artificial intelligence-based preoperative evaluation system and anesthesiologist assessment, including American Society of Anesthesiologists (ASA) physical status classification and overall perioperative risk stratification. Agreement will be evaluated using appropriate statistical measures.

    At the time of preoperative evaluation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients aged 18 years and older who were scheduled for elective surgical procedures and underwent routine preoperative evaluation at a tertiary care university hospital. Preoperative risk assessments performed by anesthesiologists were compared with artificial intelligence-based risk assessments using the same clinical data.

You may qualify if:

  • \- Adult patients aged 18 years and older
  • Patients scheduled for elective surgery under anesthesia
  • Patients who underwent routine preoperative evaluation
  • Availability of complete preoperative clinical data required for both anesthesiologist and artificial intelligence-based assessment

You may not qualify if:

  • \- Patients younger than 18 years
  • Emergency surgery cases
  • Patients with incomplete or missing preoperative clinical data
  • Patients who declined participation or whose data could not be evaluated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Faculty of Medicine, Kanuni Training and Research Hospital,

Trabzon, Trabzon, Turkey (Türkiye)

Location

Study Officials

  • Gülgün E Aksoy, MD

    Trabzon Faculty of Medicine, Kanuni Training and Research Hospital, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 23, 2026

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

October 30, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The study has been completed, and no prospectively defined plan for data sharing was included in the study protocol or the ethics committee approval.

Locations