- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395713
The Predictability of the Necessity for Cardiology Consultation in Patients Scheduled for Non-Cardiac Surgery Using Artificial Intelligence Models in Preoperative Anesthesia Assessment
The Effectiveness of Using Artificial Intelligence (Chat GPT) in Cardiac Assessment During Anesthesia Examination of Preoperative Cases
Structured Summary Title
Predictability of Cardiology Consultation Requirement in Patients Undergoing Non-Cardiac Surgery Using Artificial Intelligence Models
Background
Preoperative cardiac risk assessment is essential for minimizing perioperative morbidity and mortality in patients undergoing non-cardiac surgery. Cardiology consultations are often requested to assess surgical eligibility and reduce complication risks. However, unnecessary consultations may contribute to inefficient healthcare resource utilization and procedural delays.
Recent advances in artificial intelligence, particularly large language models, have demonstrated potential in clinical decision support systems. The European Society of Cardiology (ESC) 2024 guidelines provide a structured framework for evaluating perioperative cardiac risk. This study aims to investigate whether AI-based models can assist in predicting the need for cardiology consultation and to examine the effect of prompted versus non-prompted input formats on AI recommendations.
Study Design
Prospective, observational, comparative study.
Ethical Approval
The study has been approved by the Bursa City Hospital Ethics Committee and will be conducted in accordance with the Declaration of Helsinki.
Sample Size
Sample size was calculated using G*Power software based on anticipated effect size and statistical power requirements.
Participants
Inclusion Criteria:
Adults aged 18 years or older
ASA physical status I-IV
Scheduled for non-cardiac surgery
Evaluated by anesthesia residents with less than two years of clinical experience
Exclusion Criteria:
Pediatric patients
Patients declining participation
Incomplete clinical data
Data Collection
The following patient data will be recorded:
Demographics (age, sex, BMI)
Medical history (comorbidities, medication use, allergies, substance use)
Functional capacity (METs score)
ECG findings
Chest radiography findings
Planned surgical procedure characteristics
AI Model Evaluation
Multiple AI language models will be tested using standardized patient scenarios. Each scenario will be presented in two formats:
Prompted format:
"You are a 10-year experienced anesthesiologist. According to ESC 2024 guidelines, evaluate whether this patient requires cardiology consultation."
Non-prompted format:
"Evaluate whether this patient requires cardiology consultation."
AI recommendations will not influence clinical decision-making.
Outcome Measures
Primary and secondary analyses will include:
Agreement between AI recommendations and expert anesthesiologist evaluations
Readability of AI-generated responses
Quality assessment of responses
Classification performance comparisons across models
Statistical Analysis
Statistical analyses will be performed using appropriate comparative and agreement tests. Readability and quality scores will be analyzed using non-parametric methods where applicable. ROC analysis will be used to assess classification ability. A significance level of p < 0.05 will be applied.
Study Objective
The objective of this study is to explore the feasibility of AI-assisted decision support systems in predicting cardiology consultation requirements and to evaluate whether prompt engineering influences AI performance.
Study Overview
Status
Conditions
Detailed Description
Structured Summary Title
Predictability of Cardiology Consultation Requirement in Patients Undergoing Non-Cardiac Surgery Using Artificial Intelligence Models
Background
Preoperative cardiac risk assessment is essential for minimizing perioperative morbidity and mortality in patients undergoing non-cardiac surgery. Cardiology consultations are often requested to assess surgical eligibility and reduce complication risks. However, unnecessary consultations may contribute to inefficient healthcare resource utilization and procedural delays.
Recent advances in artificial intelligence, particularly large language models, have demonstrated potential in clinical decision support systems. The European Society of Cardiology (ESC) 2024 guidelines provide a structured framework for evaluating perioperative cardiac risk. This study aims to investigate whether AI-based models can assist in predicting the need for cardiology consultation and to examine the effect of prompted versus non-prompted input formats on AI recommendations.
Study Design
Prospective, observational, comparative study.
Ethical Approval
The study has been approved by the Bursa City Hospital Ethics Committee and will be conducted in accordance with the Declaration of Helsinki.
Sample Size
Sample size was calculated using G*Power software based on anticipated effect size and statistical power requirements.
Participants
Inclusion Criteria:
Adults aged 18 years or older
ASA physical status I-IV
Scheduled for non-cardiac surgery
Evaluated by anesthesia residents with less than two years of clinical experience
Exclusion Criteria:
Pediatric patients
Patients declining participation
Incomplete clinical data
Data Collection
The following patient data will be recorded:
Demographics (age, sex, BMI)
Medical history (comorbidities, medication use, allergies, substance use)
Functional capacity (METs score)
ECG findings
Chest radiography findings
Planned surgical procedure characteristics
AI Model Evaluation
Multiple AI language models will be tested using standardized patient scenarios. Each scenario will be presented in two formats:
Prompted format:
"You are a 10-year experienced anesthesiologist. According to ESC 2024 guidelines, evaluate whether this patient requires cardiology consultation."
Non-prompted format:
"Evaluate whether this patient requires cardiology consultation."
AI recommendations will not influence clinical decision-making.
Outcome Measures
Primary and secondary analyses will include:
Agreement between AI recommendations and expert anesthesiologist evaluations
Readability of AI-generated responses
Quality assessment of responses
Classification performance comparisons across models
Statistical Analysis
Statistical analyses will be performed using appropriate comparative and agreement tests. Readability and quality scores will be analyzed using non-parametric methods where applicable. ROC analysis will be used to assess classification ability. A significance level of p < 0.05 will be applied.
Study Objective
The objective of this study is to explore the feasibility of AI-assisted decision support systems in predicting cardiology consultation requirements and to evaluate whether prompt engineering influences AI performance.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Bursa
-
Bursa, Bursa, Turkey (Türkiye), 16001
- Bursa Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adults aged 18 years or older
ASA physical status classification I-IV
Scheduled for non-cardiac surgery
Patients evaluated preoperatively by anesthesia residents with less than two years of clinical experience
Availability of complete clinical data including medical history, ECG findings, and chest radiography
Ability to provide informed consent
Exclusion Criteria:
Patients younger than 18 years of age
Patients undergoing cardiac surgery
Patients with incomplete clinical data
Patients who declined participation
Emergency surgery cases
Patients unable to undergo standard preoperative evaluation
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 Model Recommendations and Expert Anesthesiologist Decision Regarding Cardiology Consultation Requirement
Time Frame: At baseline preoperative evaluation (Day 1)
|
The level of agreement between artificial intelligence model recommendations and expert anesthesiologist evaluations for cardiology consultation necessity will be assessed using Cohen's Kappa coefficient based on ESC 2024 guidelines.
|
At baseline preoperative evaluation (Day 1)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readability of AI-Generated Responses
Time Frame: Immediately after AI-generated response evaluation (Day 1)
|
The readability of AI-generated responses will be assessed using the Ateşman Readability Index to determine clarity and comprehensibility of consultation recommendations.
|
Immediately after AI-generated response evaluation (Day 1)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: eralp çevikkalp, Bursa Şehir Hastanesi
Publications and helpful links
General Publications
- 1.M. Graeßner et al., "Enabling personalized perioperative risk prediction by using a machinelearning model based on preoperative data," Scientific Reports, vol. 13, no. 1, May 2023, doi: 10.1038/s41598-023-33981-8. 2.B. Choi et al., "Prediction Model for 30-Day Mortality after Non-Cardiac Surgery Using MachineLearning Techniques Based on Preoperative Evaluation of Electronic Medical Records," Journal of Clinical Medicine, vol. 11, no. 21, p. 6487, Nov. 2022, doi: 10.3390/jcm11216487. 3.M. Vine et al., "Innovative approaches to preoperative care including feasibility, efficacy, and ethical implications: a narrative review," AME Surgical Journal, vol. 4. AME Publishing Company, p. 1, Feb. 01, 2024. doi: 10.21037/asj-23-41. 4.P. Chung, C. T. Fong, A. M. Walters, N. Aghaeepour, M. Yetişgen, and V. N. O'Reilly-Shah, "Large Language Model Capabilities in Perioperative Risk Prediction and Prognostication," JAMA Surgery, vol. 159, no. 8, American Medical Association, p. 928, Jun. 05, 2024. doi: 10.1001/jamasurg.2024.1621 5.T. Yurttas, R. Hidvegi, and M. Filipovic, "Biomarker-Based Preoperative Risk Stratification for Patients Undergoing Non-Cardiac Surgery," Journal of Clinical Medicine, vol. 9, no. 2, p. 351, Jan. 2020, doi: 10.3390/jcm9020351 6.J. Stones and D. Yates, "Clinical risk assessment tools in anaesthesia," BJA Education, vol. 19, no. 2. Elsevier BV, p. 47, Dec. 15, 2018. doi: 10.1016/j.bjae.2018.09.009. 7. Engineering as an Important Emerging Skill for Medical Professionals: Tutorial. J Med Internet Res. 2023 Oct 4;25:e50638. doi: 10.2196/50638. PMID: 37792434; PMCID: PMC10585440. 8. ATEŞMAN, Ender. (1997). Türkçe'de okunabilirliğin Ölçülmesi. A.Ü. Tömer Dil Dergisi, sayı:58,s.171174. 9. Coskun B, Ocakoglu G, Yetemen M, Kaygisiz O. Can ChatGPT, an Artificial Intelligence Language Model, Provide Accurate and High-quality Patient Information on Prostate Cancer? Urology. 2023 Oct;180:35-58. doi: 10.1016/j.urology.2023.05.040. Epub 2023 Jul 4. PMID: 37406
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- Bursa Şehir Hastanesi
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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