AI-assisted Analgesia Copilot System for Proper Management of Nociception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To develop and implement the SEASCAPE
研究概览
简要总结
The primary objective of the SEASCAPE project is to design, develop, and to apply a clinical implementation tool of a machine learning (ML) and artificial intelligence (AI)-based co-pilot system for the real-time monitoring and control of nociception during general anesthesia (GA).
The ultimate clinical purpose is to optimize individualized pain management by achieving precise titration of intravenous opioids (specifically remifentanil), thereby minimizing the incidence of over- and under-dosing. This optimization is projected to enhance patient outcomes, reduce opioid-related complications, and improve overall cost-effectiveness of anesthetic procedures.
The main scientific question guiding this work is: Can a novel algorithm be generated and validated to provide superior analytical precision for analgesic management by reliably differentiating genuine nociceptive responses from confounding physiological variables-such as inadequate neuromuscular blockade or changes in depth of anesthesia-thereby significantly improving the clinical decision-making framework for intraoperative nociception control? This project addresses the recognized challenge in anesthesiology: defining an objective measure to quantify nociception and antinociception during GA.
Study Population: Patients scheduled for elective surgical procedures requiring general anesthesia (GA).
Existing Intervention: The standard anesthetic regimen includes continuous intravenous infusion of the remifentanil for intraoperative analgesia, typically governed by a Target Controlled Infusion (TCI) system utilizing a pharmacokinetic/pharmacodynamic (PK/PD) model (Eleveld TCI model).
Project Focus: The research seeks to improve the accuracy and efficacy of this existing analgesic strategy by integrating a multivariate patient data stream with the newly developed SEASCAPE co-pilot AI. This aims to refine the remifentanil dose predictions beyond the current TCI model's capabilities, personalized system.
详细描述
The assessment of pain during General Anesthesia (GA) constitutes a significant clinical challenge because the direct evaluation of pain is impossible due to the abolition of conscious responses. Consequently, clinicians are required to interpret a large volume of indirect physiological data (heart rate, blood pressure, EEG, skin conductance) to determine the level of nociception-the process of detecting noxious stimuli by the nervous system-with data captured from multiple, often independent, monitors.
This manual method is intrinsically inefficient and susceptible to errors in judgment. The result of this deficiency is suboptimal pain management, where the over- or under-dosing of opioids increases the risk of serious adverse events, such as the chronification of pain. This represents a public health problem that causes disability and a significant deterioration in the quality of life. The opportunity to improve this management lies in the integration of data through advanced technologies. Although pharmacokinetic/pharmacodynamic (PK/PD) models exist to estimate individualized opioid doses, they are insufficient on their own. Their validation has primarily relied on EEG parameters, without considering the total complexity of the physiological variables involved in the nociception. The information gap and the inherent inefficiency of the current manual process open the door for a disruptive solution: the development of a co-pilot system based on Machine Learning (ML)/AI, framed within the line of biotechnology to face global challenges.
This project proposes leveraging the opportunity of ML to develop a co-pilot system capable of intelligently integrating the remifentanil PK/PD model with real-time data from multiple monitors (hemodynamic, EEG, neuromuscular relaxation, and nociception). The solution aims for the individualized optimization of pain management, minimizing the risk of inappropriate dosing. Implementing this technology is crucial, as failure to do so would perpetuate the inefficiency and enormous expenses associated with poor clinical outcomes. Conversely, this system promises to improve postoperative outcomes, such as reduce the incidence of persistent pain, and generate a direct positive impact on healthcare costs and quality of care.
The SEASCAPE clinical co-pilot seeks to integrate real-time data from multiparameter monitors, EEG, TOF (Train-of-Four), ANI (Analgesia Nociception Index), ventilators, and infusion pumps via the Mindray m-Connect platform.
Assist in decision-making by classifying nociception and generating prioritized alerts ("increase," "maintain," or "decrease" remifentanil dose).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective surgery with general anesthesia.
- •Surgeries scheduled to last at least two hours.
排除标准
- •Patients undergoing emergency surgery.
- •Pregnant women.
- •Presence of a mental or intellectual disability before the hospitalization.
- •Drug dependence.
- •Surgeries scheduled for more than 4 hours.
- •Intraoperative complications requiring changes in routine behavior.
研究组 & 干预措施
Patients
Patients from 0 to 99 years of age from whom records of the received GA will be extracted.
干预措施: Hemodynamic monitor, BIS, TOF, ANI, anesthesia machine and infusion pumps (Combination Product)
Anaesthesiologist
Anesthesiologists who will use the Seascape in its pilot mode
干预措施: SEASCAPE (Device)
结局指标
主要结局
To develop and implement the SEASCAPE
时间窗: From the beginning of the anesthetic process to the end of the anesthesia
To develop and implement a machine learning-based copilot system for monitoring nociception in patients under general anesthesia with remifentanil target-controlled infusion (TCI) analgesia using the Eleveld model, to assist clinicians in intraoperative decision-making and optimize nociception management.
次要结局
- Nociceptive patterns(From the beginning of the anesthetic process to the end of the anesthesia)
- Patterns of anesthetic depth and inadequate muscle relaxation(From the beginning of the anesthetic process to the end of the anesthesia)
- Degree of usability of the SEASCAPE(From the beginning of the anesthetic process to the end of the anesthesia)
研究者
Victor Contreras, MSN
Principal Investigator, Associate Researcher
Pontificia Universidad Catolica de Chile
