Evaluation of the Success of Artificial Intelligence Models in Interpreting Arterial Waveform Analysis Data

NCT06828575 | Recruiting

• 1 other identifier: mostcare
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the ability of artificial intelligence (AI) models to interpret arterial waveform analysis data obtained from a hemodynamic monitoring system in adult patients undergoing elective surgery. The main questions it aims to answer are: Can AI models (ChatGPT-4 and Gemini 2.0) accurately detect hemodynamic abnormalities in arterial waveform data? How well do AI-generated diagnoses align with expert anesthesiologist assessments? Are AI-generated treatment recommendations clinically appropriate? Participants will: Undergo standard hemodynamic monitoring with an arterial waveform analysis device (MostCare). Have their anonymized hemodynamic data analyzed by AI models for abnormality detection, diagnosis suggestions, and treatment recommendations. Have AI-generated results reviewed and validated by experienced anesthesiologists. This study aims to assess whether AI models can serve as decision-support tools in perioperative and critical care settings by improving the interpretation of complex hemodynamic data, potentially enhancing patient safety, diagnostic accuracy, and clinical efficiency.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Accuracy of AI models in detecting hemodynamic abnormalities (True or False).

  1 day

Secondary Outcomes (2)

• Concordance Between AI-Generated Diagnoses and Expert Anesthesiologist Diagnoses

  1 DAY

• Clinical Appropriateness of AI-Generated Treatment Recommendations

  1 DAY

Interventions

predictions OTHER

predictions of learning language models

Eligibility Criteria

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

Study Population

This study will include adult patients (≥18 years old) undergoing elective surgery requiring intraoperative arterial waveform monitoring as part of routine perioperative care. The population will consist of patients from two tertiary-level hospitals where advanced hemodynamic monitoring with the MostCare system is regularly utilized. Participants will be selected based on their eligibility for continuous arterial pressure monitoring, ensuring a standardized dataset for AI analysis. The study population will represent a diverse range of surgical procedures, including but not limited to: General surgery (e.g., abdominal, hepatobiliary, colorectal procedures)

You may qualify if:

• Age ≥ 18 years
• Undergoing elective surgery with arterial waveform monitoring as part of standard perioperative care
• Hemodynamic data successfully recorded using the MostCare hemodynamic monitoring system
• Able to provide informed consent to participate in the study

You may not qualify if:

• Incomplete or corrupted hemodynamic data (e.g., signal artifacts preventing reliable analysis)
• Emergency surgery cases
• Patients with severe arrhythmias or hemodynamic instability that might interfere with arterial waveform interpretation
• Refusal to participate or withdrawal of consent
• Patients with contraindications to arterial catheterization (e.g., coagulopathy, severe peripheral vascular disease)

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Drug Development

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Engin ihsan Turan, Specialist

CONTACT

05382431114; enginihsan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: February 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 16, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

TU (1)