Perioperative Risk AssessmentASA-AINCT07399938
Frailty Assessment Reveals Cognitive Differences in ASA Classification: Anesthesiologists vs Large Language Models
An observational study of Perioperative Risk Assessment, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative Risk Assessment
- What is being tested?
- Observational Assessment Only
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged 18 years and older
- Scheduled for elective surgical procedures
- Availability of standardized preoperative clinical data sufficient for ASA Physical -Status Classification Exclusion Criteria
- Emergency surgical procedures
- Pediatric patients
- Patients with insufficient or incomplete clinical data preventing ASA Physical --Status assessment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
Official title: Explicit Frailty Integration Reveals Cognitive Differences in ASA Classification Between Anesthesiologists and Large Language Models
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.
Read more
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.
Read the detailed description
This study is designed as a prospective, observational, comparative, multirater investigation evaluating differences in ASA Physical Status Classification between anesthesiologists and large language models (LLMs).
The ASA Physical Status Classification System is a cornerstone of perioperative risk assessment; however, it lacks explicit incorporation of frailty, a multidimensional concept reflecting reduced physiological reserve and vulnerability. In clinical practice, anesthesiologists often integrate frailty-related information implicitly into ASA assessments, potentially contributing to interobserver variability.
Large language models process clinical information using explicit, structured inputs and do not rely on experiential or intuitive reasoning. This characteristic provides a unique opportunity to explore cognitive differences between human experts and artificial intelligence in clinical classification tasks.
Adult patients (≥18 years) scheduled for elective surgery will be included. Emergency cases, pediatric patients, and individuals with insufficient clinical data to allow ASA classification will be excluded. For each patient, standardized preoperative clinical data will be collected, including demographic characteristics, body mass index, comorbidities, regular medications, and type of planned surgical procedure.
ASA Physical Status Classification will be independently assigned by four board-certified anesthesiologists with at least five years of clinical experience, as well as by two large language models developed by different organizations. All evaluations will be conducted using the same standardized dataset, and evaluators will be blinded to each other's assessments.
The study will be conducted in two sequential phases. In the first phase, ASA classification will be performed using standard clinical data alone. In the second phase, a validated frailty index will be added to the same patient dataset, and the evaluation process will be repeated. This design will allow assessment of how frailty information affects ASA classification decisions in human and artificial intelligence evaluators.
Large language models will be prompted using a predefined, standardized prompt that remains unchanged throughout the study. Models will be instructed to generate a single ASA Physical Status category (I-V) without providing explanations or additional commentary, and no iterative prompting or feedback will be allowed.
Interrater agreement among anesthesiologists, between artificial intelligence models, and between human and artificial intelligence evaluators will be analyzed using Cohen's Kappa and Fleiss' Kappa statistics, as appropriate. Changes in ASA classification following the addition of frailty information will be evaluated using paired statistical methods. Statistical significance will be defined as p < 0.05.
By comparing ASA classification patterns between anesthesiologists and large language models, both with and without frailty data, this study aims to clarify the role of implicit and explicit reasoning in perioperative risk assessment and to contribute to the development of future artificial intelligence-assisted clinical decision-support systems.
- Conditions
- Perioperative Risk Assessment
- Being tested
- Observational Assessment Only
- Keywords
- ASA Physical Status Classification, Artificial Intelligence, Large Language Models, Anesthesiology, Frailty, Preoperative Assessment, Clinical Decision Support, Interrater Agreement, Kappa Statistics
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of preoperative evaluation, prior to surgery
Secondary outcomes (3)
Effect of Frailty Information on ASA Physical Status Classification
Change in ASA Physical Status Classification assigned by anesthesiologists and large language models after the addition of a frailty index to standardized preoperative clinical data.
Measured: At the time of preoperative evaluation, prior to surgery
Agreement Between Large Language Models in ASA Physical Status Classification
Interrater agreement in ASA Physical Status Classification between two different large language models using identical standardized preoperative clinical datasets, with and without frailty information.
Measured: At the time of preoperative evaluation, prior to surgery
Agreement Among Anesthesiologists in ASA Physical Status Classification
Interrater agreement in ASA Physical Status Classification among four board-certified anesthesiologists based on standardized preoperative clinical data, with and without frailty information.
Measured: At the time of preoperative evaluation, prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start25 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Risk AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Ofluoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- cansu ofluoglu, MD, Principal investigator, ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399938
- Sponsor's protocol ID
- AI_ASA_FRAILTY_2026
- Acronym
- ASA-AI
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explicit Frailty Integration Reveals Cognitive Differences in ASA Classification Between Anesthesiologists and Large Language Models
- ClinicalTrials.gov ID
- NCT07399938
- Acronym / sponsor ID
- ASA-AI / AI_ASA_FRAILTY_2026
- Conditions
- Perioperative Risk Assessment
- Keywords
- ASA Physical Status Classification, Artificial Intelligence, Large Language Models, Anesthesiology, Frailty, Preoperative Assessment, Clinical Decision Support, Interrater Agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed as a prospective, observational, comparative, multirater investigation evaluating differences in ASA Physical Status Classification between anesthesiologists and large language models (LLMs).
The ASA Physical Status Classification System is a cornerstone of perioperative risk assessment; however, it lacks explicit incorporation of frailty, a multidimensional concept reflecting reduced physiological reserve and vulnerability. In clinical practice, anesthesiologists often integrate frailty-related information implicitly into ASA assessments, potentially contributing to interobserver variability.
Large language models process clinical information using explicit, structured inputs and do not rely on experiential or intuitive reasoning. This characteristic provides a unique opportunity to explore cognitive differences between human experts and artificial intelligence in clinical classification tasks.
Adult patients (≥18 years) scheduled for elective surgery will be included. Emergency cases, pediatric patients, and individuals with insufficient clinical data to allow ASA classification will be excluded. For each patient, standardized preoperative clinical data will be collected, including demographic characteristics, body mass index, comorbidities, regular medications, and type of planned surgical procedure.
ASA Physical Status Classification will be independently assigned by four board-certified anesthesiologists with at least five years of clinical experience, as well as by two large language models developed by different organizations. All evaluations will be conducted using the same standardized dataset, and evaluators will be blinded to each other's assessments.
The study will be conducted in two sequential phases. In the first phase, ASA classification will be performed using standard clinical data alone. In the second phase, a validated frailty index will be added to the same patient dataset, and the evaluation process will be repeated. This design will allow assessment of how frailty information affects ASA classification decisions in human and artificial intelligence evaluators.
Large language models will be prompted using a predefined, standardized prompt that remains unchanged throughout the study. Models will be instructed to generate a single ASA Physical Status category (I-V) without providing explanations or additional commentary, and no iterative prompting or feedback will be allowed.
Interrater agreement among anesthesiologists, between artificial intelligence models, and between human and artificial intelligence evaluators will be analyzed using Cohen's Kappa and Fleiss' Kappa statistics, as appropriate. Changes in ASA classification following the addition of frailty information will be evaluated using paired statistical methods. Statistical significance will be defined as p < 0.05.
By comparing ASA classification patterns between anesthesiologists and large language models, both with and without frailty data, this study aims to clarify the role of implicit and explicit reasoning in perioperative risk assessment and to contribute to the development of future artificial intelligence-assisted clinical decision-support systems.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Elective Surgery Patients | – | Other: Observational Assessment OnlyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Adult patients aged 18 years and older
- Scheduled for elective surgical procedures
- Availability of standardized preoperative clinical data sufficient for ASA Physical -Status Classification Exclusion Criteria
- Emergency surgical procedures
- Pediatric patients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Assessment OnlyThis 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. | Other | Adult Elective Surgery Patients |
Primary outcome
Interrater Agreement in ASA Physical Status Classification Between Anesthesiologists and Large Language Models
Time frame: At the time of preoperative evaluation, prior to surgery
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.
3 secondary outcomes
Effect of Frailty Information on ASA Physical Status Classification
Time frame: At the time of preoperative evaluation, prior to surgery
Agreement Between Large Language Models in ASA Physical Status Classification
Time frame: At the time of preoperative evaluation, prior to surgery
Agreement Among Anesthesiologists in ASA Physical Status Classification
Time frame: At the time of preoperative evaluation, prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cansu ofluoglu, MD principal investigator
ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Risk Assessment, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater Agreement in ASA Physical Status Classification Between Anesthesiologists and Large Language Models (time frame: At the time of preoperative evaluation, prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.