- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629350
ASA Prediction Using Health Data and Medication Use
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3015GD
- Erasmus MC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Age <18 at moment of surgery, or
- ASA-PS V-VI, or
- Opt-out registered in EMR
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The American Society of Anesthesiologists physical status (ASA-PS) class
Time Frame: Day 0
|
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.
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Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance metrics: accuracy
Time Frame: day 0
|
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).
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day 0
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Performance metrics: precision
Time Frame: day 0
|
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)
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day 0
|
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Performance metrics:recall
Time Frame: day 0
|
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)
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day 0
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Performance metrics: F1-score
Time Frame: day 0
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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).
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day 0
|
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Performance metrics: Area Under the Receiver Operating Characteristic Curve
Time Frame: day 0
|
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).
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day 0
|
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Calibration
Time Frame: Day 0
|
Calibration plots will be used to assess the agreement between predictions and the event rate (i.e.
correct classification).
|
Day 0
|
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Misclassification of the ASA-PS score
Time Frame: Day 0
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A manual review of a selection of misclassifications will be performed by two anesthesiologists to qualitatively assess the cause of the misclassification.
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Day 0
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Explainability of the prediction model:Shapley additive explanations (SHAP)
Time Frame: day 0
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Shapley additive explanations (SHAP) if applicable, as it can offer insights into the contribution of each feature to the prediction of individual instances.
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day 0
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Explainability of the prediction model:Local interpretable model-agnostic explanations (LIME)
Time Frame: day 0
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Local interpretable model-agnostic explanations (LIME) can offer insights into the contribution of each feature to the prediction of individual instances.
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day 0
|
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Optimal sample size
Time Frame: day 0
|
Analysis of the learning curves to determine if additional data would likely improve the model's performance or if the current dataset is sufficient.
|
day 0
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan-Wiebe Korstanje, MD MSc PhD, Erasmus Medical Center
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
- MEC-2020-0051/MEC-2024-0181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
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.
Clinical Trials on ASA-PS Classification
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University Clinic FrankfurtActive, not recruiting
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Bursa City HospitalCompletedPreoperative Risk Assessment | ASA Physical Status ClassificationTurkey (Türkiye)
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Indonesia UniversityCompletedElective Surgical Procedure | ASA Physical Status I | ASA Physical Status IIIndonesia
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BAIBYS FertilityActive, not recruiting
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Yale UniversityWithdrawnPatients With "ASA 3" DesignationUnited States
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Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompletedAnesthesia | ASA Physical Status I | ASA Physical Status IIFrance
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AllerganCompletedPatients Who Participated in an Intravitreal Brimo PS DDS® StudyFrance, United Kingdom, Korea, Republic of, Czech Republic, Australia, Israel, India, Portugal, Germany, United States, Italy, Philippines
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Sohag UniversityCompletedRobson Classification SystemEgypt
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Sohag UniversityActive, not recruitingCaesrean Section Rates | Robson ClassificationEgypt
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University of California, IrvineWithdrawnAnesthetized Healthy Patients (ASA 1 or 2) in the Supine Position, Excluding Head, Neck and Head Surgeries | Anesthetized Patient With Severe Systemic Disease (ASA 3 or 4)United States