AzTrials
AzTrials

AnesthesiaASA-LLMNCT07696221

Large Language Models Versus Anesthesiologists for ASA Physical Status Classification

An observational study of Anesthesia and Preoperative Risk Prediction, run by Marmara University Pendik Training and Research Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

The American Society of Anesthesiologists Physical Status (ASA-PS) classification is a cornerstone of preoperative risk assessment, yet interrater variability among clinicians is well documented. Read more about this study

Who is it for?
Ages 18 years and older
How many people
350 participants
Where
No sites listed yet
Study dates
21 Jul 2026to 21 Oct 2026
Phase
Observational

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who underwent preoperative anesthesia evaluation before elective surgery at a tertiary university hospital in Istanbul, Turkey.

Who may be able to join

  • Age 18 years or older
  • Planned elective surgery
  • Completed preoperative anesthesia evaluation

Who cannot join

  • Emergency surgical procedures
  • ASA VI (brain death)
  • Incomplete clinical records

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dilara Göçmen, Assistant Prof contact

+905413439438

dilara.gocmen@marmara.edu.tr

About this study

Official title: Comparison of Clinical Assessment and Large Language Models in Preoperative Risk Classification: A Retrospective Analysis of ChatGPT, DeepSeek, Gemini, and Claude in ASA Physical Status Classification

The American Society of Anesthesiologists Physical Status (ASA-PS) classification is a cornerstone of preoperative risk assessment, yet interrater variability among clinicians is well documented. Large language models (LLMs) have recently demonstrated expert-level performance in several clinical classification tasks, including ASA-PS assignment.

This retrospective observational study evaluates whether four widely used LLMs - ChatGPT, DeepSeek, Gemini, and Claude - can accurately and consistently assign ASA-PS classes from structured, fully anonymized clinical vignettes derived from real preoperative anesthesia evaluations, using a consensus of senior anesthesiologists as the reference standard.

No patient data will be transmitted to third-party platforms. Clinical information will be converted by the investigators into de-identified structured vignettes containing only age range, sex, body mass index range, presence or absence of systemic diseases, functional capacity, and the major/minor nature of the planned surgery, in full compliance with national data protection legislation (KVKK).

Read the detailed description

Adult patients who underwent preoperative anesthesia evaluation before elective surgery at Marmara University Pendik Training and Research Hospital will be included retrospectively. For each patient, demographic data (age, sex, body mass index), systemic comorbidities (hypertension, diabetes mellitus, coronary artery disease, chronic obstructive pulmonary disease, and others), functional capacity (metabolic equivalents, MET), type of planned surgery (major/minor), and the ASA-PS class assigned by the attending anesthesiologist will be recorded.

Clinical data will be anonymized and converted into structured clinical vignettes by the investigators. Vignettes will contain no identifiers, dates, protocol numbers, or rare diagnostic combinations that could directly or indirectly identify a patient.

Standardization of the LLM assessment process: To ensure independence between assessments, each vignette will be evaluated in a separate, history-free session. A new conversation will be initiated in the relevant model for every patient vignette, thereby eliminating the possibility that the model is influenced by its responses to previous vignettes (context anchoring). The ASA-PS class assigned to one vignette will not be carried over as context into the evaluation of any subsequent vignette. Each vignette will be presented to all four models using an identical, standardized prompt requesting only an ASA-PS class (I-VI) with a brief rationale, in a strictly defined output format. Model outputs will play no role in clinical decision-making. External information retrieval by the models will be disabled, and all queries will be completed within a narrow time window to minimize variability in model versions.

Each vignette will be submitted to each model once (single querying). Consequently, the intra-model test-retest reliability of the LLMs will not be assessed; this is acknowledged as a study limitation, consistent with the probabilistic nature of large language models, which may produce between-session variability in their outputs.

Model versions: The current version of each model available at the time of data collection will be used - ChatGPT (GPT-5.5, OpenAI), Gemini (Gemini 3.5, Google DeepMind), DeepSeek (DeepSeek V4, DeepSeek AI), and Claude (Claude Opus 4.8, Anthropic). These versions reflect the versions current at the time of protocol submission; the most recent stable version of each model accessible during data collection will be used, and the exact version and access date will be recorded. Because publicly available chat interfaces may perform automatic background routing to different model tiers, this is acknowledged as a reproducibility limitation.

The reference standard ASA-PS class will be determined by an independent, blinded panel of at least three senior anesthesiologists; consensus or majority vote will define the reference classification.

Statistical analysis: The primary (confirmatory) analysis will quantify the agreement between each LLM and the reference standard using quadratic weighted Cohen's kappa, respecting the ordinal structure of ASA-PS. Multi-rater agreement across the four models and the human raters will be assessed with Fleiss' kappa. Pairwise accuracy comparisons among the four models (six pairwise contrasts) will be treated as secondary/exploratory analyses and compared with McNemar or permutation tests for paired data, applying correction for multiple comparisons (e.g., Bonferroni or Holm); 95% confidence intervals will be estimated by bootstrap methods. Prespecified subgroup analyses include ASA III-IV boundary cases, multimorbidity burden, major versus minor surgery, and rater experience.

Primary hypothesis: The ASA-PS assignments of the LLMs (ChatGPT, DeepSeek, Gemini, and Claude) will show at least good agreement with the reference standard (weighted kappa ≥ 0.60). Secondary hypothesis: LLM errors will cluster in specific subgroups (e.g., the ASA III-IV boundary, multimorbid patients).

Keywords
asa physical status, large language models, artificial intelligence, chatgpt, gemini, deepseek, Claude, risk classification
Medical subject headings
Brain Stem Infarctions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07696221
Study groupRoleWhat they receive
elective surgery patientsAdult patients (≥18 years) who underwent preoperative anesthesia evaluation before elective surgery. Anonymized structured vignettes derived from their records will be classified by four LLMs (ChatGPT, DeepSeek, Gemini, Claude) and by a blinded senior anesthesiologist panel serving as the reference standard.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement between LLM-assigned and reference-standard ASA-PS class

    Quadratic weighted Cohen's kappa between each large language model's ASA-PS assignment (ChatGPT, DeepSeek, Gemini, Claude) and the reference standard defined by consensus of a blinded panel of at least three senior anesthesiologists. Agreement of at least "good" level (weighted kappa ≥ 0.60) is hypothesized.

    Measured: Through study completion, an average of 3 months

Secondary outcomes (2)
  1. Overall classification accuracy of each LLM

    Proportion of vignettes in which the LLM-assigned ASA-PS class exactly matches the reference standard, with exploratory pairwise comparisons among the four models (McNemar/permutation tests, corrected for multiple comparisons)

    Measured: Through study completion, an average of 3 months

  2. Subgroup error patterns

    Frequency and direction (over- vs. under-classification) of LLM misclassifications in prespecified subgroups: ASA III-IV boundary, multimorbidity, major vs. minor surgery

    Measured: Through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start21 Jul 2026 (estimated)
  3. Primary completion21 Aug 2026 (estimated)
  4. Study completion21 Oct 2026 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07696221
Sponsor's protocol ID
ASA-LLM-2026
Acronym
ASA-LLM
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen YH, Ruan SJ, Chen PF. Predicting 30-Day Postoperative Mortality and American Society of Anesthesiologists Physical Status Using Retrieval-Augmented Large Language Models: Development and Validation Study. J Med Internet Res. 2025 Jun 3;27:e75052. doi: 10.2196/75052.

    PubMed 40460423
  • Cheng T, Li Y, Gu J, He Y, He G, Zhou P, Li S, Xu H, Bao Y, Wang X. The performance of ChatGPT in day surgery and pre-anesthesia risk assessment: a case-control study of 150 simulated patient presentations. Perioper Med (Lond). 2024 Nov 21;13(1):111. doi: 10.1186/s13741-024-00469-6.

    PubMed 39574189
  • Yoon SB, Lee J, Lee HC, Jung CW, Lee H. Comparison of NLP machine learning models with human physicians for ASA Physical Status classification. NPJ Digit Med. 2024 Sep 28;7(1):259. doi: 10.1038/s41746-024-01259-6.

    PubMed 39341936
  • Chung P, Fong CT, Walters AM, Aghaeepour N, Yetisgen M, O'Reilly-Shah VN. Large Language Model Capabilities in Perioperative Risk Prediction and Prognostication. JAMA Surg. 2024 Aug 1;159(8):928-937. doi: 10.1001/jamasurg.2024.1621.

    PubMed 38837145
  • Turan EI, Baydemir AE, Ozcan FG, Sahin AS. Evaluating the accuracy of ChatGPT-4 in predicting ASA scores: A prospective multicentric study ChatGPT-4 in ASA score prediction. J Clin Anesth. 2024 Sep;96:111475. doi: 10.1016/j.jclinane.2024.111475. Epub 2024 Apr 23.

    PubMed 38657530

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in