- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407998
AI-Based ASA Classification in Preoperative Patients (AI-Based ASA C)
Evaluation of Artificial Intelligence Models in Assigning American Society of Anesthesiologists Physical Status Classification in Preoperative Patients: A Prospective Observational Study
Study Overview
Status
Detailed Description
The American Society of Anesthesiologists Physical Status (ASA-PS) classification is widely used for perioperative risk stratification but is subject to interobserver variability. Recent advances in artificial intelligence and large language models have introduced new opportunities for clinical decision support.
This prospective observational study includes adult patients undergoing routine preoperative anesthesia evaluation at Bursa City Hospital. Demographic data, medical history, comorbidities, functional capacity, laboratory findings, electrocardiography, chest imaging results, and planned surgical procedures are recorded to construct standardized clinical scenarios.
Multiple artificial intelligence models, including large language model-based systems, are provided with patient scenarios using both structured prompts and unstructured inputs. Each model assigns an ASA-PS classification and provides explanatory text. AI-generated classifications are compared with assessments performed independently by experienced anesthesiologists.
Primary outcomes include agreement and accuracy between AI-generated and clinician-assigned ASA classifications using Cohen's Kappa statistics. Secondary outcomes include readability assessment using the Ateşman Turkish Readability Index and response quality evaluation using the Global Quality Scale.
The study aims to explore whether artificial intelligence can improve standardization, objectivity, and efficiency in preoperative risk assessment while highlighting the strengths and limitations of current AI technologies in clinical anesthesia practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey (Türkiye), 16110
- Bursa City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years or older
- Undergoing routine preoperative anesthesia evaluation
- Classified as ASA Physical Status I-IV
- Availability of complete clinical data required for AI assessment
Exclusion Criteria:
- Patients younger than 18 years
- Refusal to participate
- Incomplete or missing clinical information
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between AI-Generated and Clinician-Assigned ASA Physical Status Classification
Time Frame: Preprocedural/Perioperative
|
Level of agreement between artificial intelligence models and anesthesiologists in assigning ASA Physical Status classification measured using Cohen's Kappa coefficient
|
Preprocedural/Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of AI Models in ASA Classification
Time Frame: Preprocedural/Perioperative
|
Proportion of correct ASA Physical Status classifications generated by artificial intelligence models compared with anesthesiologist assessments
|
Preprocedural/Perioperative
|
|
Readability of AI-Generated Clinical Responses
Time Frame: Preprocedural/Perioperative
|
Readability scores of artificial intelligence-generated clinical responses assessed using the Ateşman Turkish Readability Index (range: 0-100), where higher scores indicate better readability.
|
Preprocedural/Perioperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Bursa City Hospital 004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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