CClinicalTrials.gg
CompletedNCT06629350Updated May 18, 2025

ASA Prediction Using Health Data and Medication Use

An observational study in ASA-PS Classification, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Erasmus Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
149,422
Ages
18 Years and older
Sex
All
01

Study summary

The development of a machine learning algorithm that predicts American Society of Anesthesiologist-Physical Status (ASA-PS) based on preoperative variables would not only improve clinical decision-making in patient risk stratification but also offer a more reliable tool for administrative and regulatory uses. Therefore, the development of such a machine learning tool presents a significant opportunity to advance both the science and practice of perioperative care. Incorporating medication use into the algorithm could further enhance its predictive power, as it is closely linked to systemic disease. This addition could help refine the ASA-PS classification, making it an even more valuable tool in the clinical setting.

Read the detailed description

The American Society of Anesthesiologists Physical Status (ASA-PS) classification system is a widely used tool for assessing surgical fitness and other clinical contexts. However, its inherent subjectivity and heavy reliance on clinician judgment can lead to inconsistencies in patient risk stratification, a critical component of perioperative care. Furthermore, the ASA-PS system has been adopted for various administrative and regulatory purposes beyond its original intent, such as quality assessment by the Dutch Health and Youth Care Inspectorate (IGJ), compensation decisions by private payers in the USA, patient triage, and determining suitability for certain types of surgery.

Given the broad and critical applications of the ASA-PS system, enhancing its precision and objectivity is of paramount importance. One way to achieve this is through the development of a machine learning algorithm that predicts ASA-PS based on preoperative variables. Anesthesiologists base the ASA-PS score on the presence of systemic diseases, which can be inferred from medication use. By leveraging data such as Anatomical Therapeutic Chemical (ATC) codes, BMI, sex, age, routinely collected preoperative health data, and medication use, this algorithm could provide a more consistent and objective measure of ASA-PS.

This would not only improve clinical decision-making in patient risk stratification but also offer a more reliable tool for administrative and regulatory uses. Therefore, the development of such a machine learning tool presents a significant opportunity to advance both the science and practice of perioperative care. Incorporating medication use into the algorithm could further enhance its predictive power, as it is closely linked to systemic disease. This addition could help refine the ASA-PS classification, making it an even more valuable tool in the clinical setting.

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Conditions studied

  • ASA-PS Classification

Keywords

  • machine learning
  • ASA-PS
  • Medication
  • Health questionnaire
03

In context

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who underwent a surgical, diagnostic or therapeutic procedure within the surgical suite of the Erasmus MC since 2018 (introduction new digital Hospital Information System) and who had a ASA-PS class recorded.

Inclusion criteria

  • Underwent a surgical, diagnostic or therapeutic procedure within the surgical suite of the Erasmus MC, and
  • ASA-PS score recorded in electronic medical record (EMR), and
  • A verified medication list in EMR, or a filled out preoperative anesthesiological health questionnaire registered in EMR

Exclusion criteria

Exclusion Criteria:

  • Age \<18 at moment of surgery, or
  • ASA-PS V-VI, or
  • Opt-out registered in EMR
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
149,422 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The American Society of Anesthesiologists physical status (ASA-PS) class

    The dependent response variable will be the ASA-PS class, both as a four-level variable (ASA-PS I, II, III and IV) and a two-level variable (ASA-PS I and II versus ASA-PS III and IV). The ASA-PS class was assigned to the patient and recorded in the patients file in the EMR by an anesthesiologist of resident anesthesiology as a part of the routinely performed preoperative anesthesiological screening in preparation for a procedure.

    Time frame: Day 0

Secondary outcomes

  1. Performance metrics: accuracy

    The correct classification of the ASA-PS score will be evaluated using performance metrics of the machine learning algorithms. Common performance metrics include: Accuracy (the proportion of correctly predicted instances).

    Time frame: day 0

  2. Performance metrics: precision

    The correct classification of the ASA-PS score will be evaluated using performance metrics of the machine learning algorithms. Common performance metrics include: precision (the ratio of true positive predictions to the total positive predictions)

    Time frame: day 0

  3. Performance metrics:recall

    The correct classification of the ASA-PS score will be evaluated using performance metrics of the machine learning algorithms. Common performance metrics include:ecall (sensitivity or the ratio of true positive predictions to the actual positive instances)

    Time frame: day 0

  4. Performance metrics: F1-score

    The correct classification of the ASA-PS score will be evaluated using performance metrics of the machine learning algorithms. Common performance metrics include: F1-score (the harmonic mean of precision and recall).

    Time frame: day 0

  5. Performance metrics: Area Under the Receiver Operating Characteristic Curve

    The correct classification of the ASA-PS score will be evaluated using performance metrics of the machine learning algorithms. Common performance metrics include:the Area Under the Receiver Operating Characteristic Curve (AUC-ROC, Measures the model's ability to discriminate between positive and negative instances).

    Time frame: day 0

  6. Calibration

    Calibration plots will be used to assess the agreement between predictions and the event rate (i.e. correct classification).

    Time frame: Day 0

  7. Misclassification of the ASA-PS score

    A manual review of a selection of misclassifications will be performed by two anesthesiologists to qualitatively assess the cause of the misclassification.

    Time frame: Day 0

  8. Explainability of the prediction model:Shapley additive explanations (SHAP)

    Shapley additive explanations (SHAP) if applicable, as it can offer insights into the contribution of each feature to the prediction of individual instances.

    Time frame: day 0

  9. Explainability of the prediction model:Local interpretable model-agnostic explanations (LIME)

    Local interpretable model-agnostic explanations (LIME) can offer insights into the contribution of each feature to the prediction of individual instances.

    Time frame: day 0

  10. Optimal sample size

    Analysis of the learning curves to determine if additional data would likely improve the model's performance or if the current dataset is sufficient.

    Time frame: day 0

07

Study locations

1 site
  • Erasmus MC
    Rotterdam, Zuid-Holland 3015GD, Netherlands
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 25, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All (Underlying) pseudonymised data will be made available alongside with the publication to execute the training and validation of the models. Data will be uploaded in dataverse.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06629350
Lead sponsor
Erasmus Medical Center
Collaborators
Health Holland
Responsible party
Jan-Wiebe Korstanje (principal investigator, Erasmus Medical Center) — Principal investigator
First posted
Oct 8, 2024
Start date
Jun 25, 2024
Primary completion
Jun 27, 2024
Completion
Jun 27, 2024
Last update
May 18, 2025

Study contacts

Jan-Wiebe Korstanje, MD MSc PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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