ASA Prediction Using Health Data and Medication Use

NCT06629350 | Completed

• 1 other identifier: MEC-2020-0051/MEC-2024-0181
• Study Type: observational
• Target: 149,422
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ASA-PS Classification

Keywords

machine learning; ASA-PS; Medication; Health questionnaire

Outcome Measures

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.

  Day 0

Secondary Outcomes (10)

• Performance metrics: accuracy

  day 0

• Performance metrics: precision

  day 0

• Performance metrics:recall

  day 0

• Performance metrics: F1-score

  day 0

• Performance metrics: Area Under the Receiver Operating Characteristic Curve

  day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Health Holland: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Study Officials

• Jan-Wiebe Korstanje, MD MSc PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: June 25, 2024
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: to be determined, based on Dutch Law
• Access Criteria: Only data requests in line with the Terms of Use will be taken into consideration. A Data Transfer Agreement (DTA) in line with European Union General Data Protection Regulation (EU-GDPR) regulations and/or the Research Collaboration Agreement (RCA) should be signed before data is shared. If a data request is approved, the data will be delivered in a safe and secure manner. By signing the DTA and/or RCA and accessing the Materials, the recipient represents his/her acceptance of the Terms of Use.

Locations

NL (1)