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临床试验/NCT07396636
NCT07396636招募中不适用

Machine Learning-Assisted Intraoperative Hypotension Management: Developing Personalized Treatment Recommendations

Nevsehir Public Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Intraoperative hypotension endotype classification (hemodynamic subtype) per hypotension episode

研究概览

简要总结

Intraoperative hypotension, defined as a drop in blood pressure during surgery, is a frequent event in patients undergoing general anesthesia. Even brief episodes of low blood pressure may reduce blood flow to vital organs such as the brain, heart, and kidneys, and have been associated with an increased risk of postoperative complications, prolonged recovery, and worse clinical outcomes. Despite its clinical importance, the management of intraoperative hypotension is often based on general guidelines and individual clinician experience rather than patient-specific physiological mechanisms.

Low blood pressure during surgery can occur for different underlying reasons, including reduced circulating blood volume, excessive vasodilation caused by anesthetic agents, impaired heart contractility, or abnormalities in heart rate. In routine practice, these mechanisms are not always clearly distinguished, and similar treatment strategies may be applied to patients with different physiological causes of hypotension. As a result, the response to treatment can vary widely between patients.

This prospective observational study aims to improve the understanding of intraoperative hypotension by collecting detailed hemodynamic data during surgery and analyzing these data using machine learning methods. The study is designed to observe current clinical practice without altering or interfering with routine patient care. All decisions regarding anesthesia management and treatment of hypotension will be made by the attending anesthesiologists according to standard clinical practice. The research team will not provide treatment recommendations during surgery.

Adult patients undergoing elective surgery under general anesthesia with continuous invasive arterial blood pressure monitoring will be included. During the intraoperative period, blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance, and other advanced hemodynamic parameters will be continuously recorded at regular intervals. When hypotension occurs, the onset, duration, and severity of the episode will be documented, along with the treatment applied, such as fluid administration, vasopressor agents, or inotropic medications. The time required for blood pressure to recover to an acceptable level will also be recorded.

The collected data will be analyzed using machine learning techniques to identify distinct subtypes of intraoperative hypotension based on physiological patterns. These subtypes may reflect different underlying mechanisms, such as hypovolemia, vasodilation, myocardial depression, or heart rate-related causes. In addition, the study will evaluate how different treatment strategies perform across these hypotension subtypes and how quickly hemodynamic stability is restored.

Patient-related factors such as age, sex, body mass index, physical status classification, and comorbid conditions will also be examined to determine their relationship with the occurrence, severity, and treatment response of hypotension episodes. By combining patient characteristics, physiological data, and treatment responses, the study aims to generate data-driven insights into personalized hypotension management.

The ultimate goal of this research is to support the development of individualized treatment recommendations for intraoperative hypotension based on objective physiological data rather than a one-size-fits-all approach. The findings of this study are expected to provide a strong scientific foundation for future clinical decision-support systems that can assist anesthesiologists in selecting the most appropriate treatment strategy for each patient. By improving the precision of blood pressure management during surgery, this approach has the potential to enhance patient safety and perioperative outcomes while maintaining standard clinical workflows.

详细描述

Intraoperative hypotension, commonly defined as a decrease in arterial blood pressure during surgery, is a frequent and clinically important event in patients undergoing general anesthesia. Numerous studies have shown that even brief periods of low blood pressure may be associated with impaired organ perfusion and an increased risk of postoperative complications, including acute kidney injury, myocardial injury, stroke, prolonged hospital stay, and increased mortality. Despite growing awareness of its clinical impact, the optimal management of intraoperative hypotension remains an ongoing challenge in anesthetic practice.

Current approaches to intraoperative blood pressure management are largely based on general thresholds, guideline recommendations, and the individual experience of anesthesiologists. In routine clinical practice, hypotension is often treated with fluid administration, vasopressor agents, inotropic drugs, or combinations of these interventions. However, hypotension is not a single, uniform clinical entity. It may arise from different underlying physiological mechanisms, such as hypovolemia, anesthetic-induced vasodilation, myocardial depression, or heart rate abnormalities. These mechanisms may coexist or change dynamically during surgery, making clinical decision-making complex.

In many cases, similar treatment strategies are applied to patients with different physiological causes of hypotension, which may lead to variable treatment responses. For example, fluid administration may be effective in patients with hypovolemia but less beneficial or even harmful in patients with predominant vasodilation or impaired cardiac function. Likewise, vasopressor therapy may rapidly restore blood pressure in vasodilatory hypotension but may not adequately address hypotension caused by low cardiac output. This highlights the need for a more individualized, physiology-based approach to intraoperative hypotension management.

Recent advances in perioperative monitoring have enabled continuous, high-resolution recording of arterial blood pressure and advanced hemodynamic parameters, such as cardiac output, stroke volume, and systemic vascular resistance. At the same time, developments in machine learning and artificial intelligence have created new opportunities to analyze large and complex datasets, identify hidden patterns, and generate data-driven insights that may not be apparent through traditional statistical methods.

The primary aim of this prospective observational study is to improve the understanding of intraoperative hypotension by integrating detailed hemodynamic monitoring with machine learning-based analysis. Rather than focusing on a single blood pressure threshold or isolated variables, this study seeks to characterize hypotension episodes as dynamic physiological events and to identify distinct hypotension subtypes based on underlying hemodynamic patterns.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years or older
  • Patients scheduled for elective surgical procedures
  • Procedures performed under general anesthesia
  • Availability of continuous invasive arterial blood pressure monitoring during the intraoperative period
  • Planned surgical duration of at least 2 hours
  • Ability to provide written informed consent for participation in the study

排除标准

  • Emergency surgery
  • Diagnosis of sepsis, septic shock, or advanced cardiogenic shock
  • Cardiac rhythm disturbances that prevent reliable hemodynamic measurements (e.g., atrial fibrillation)
  • Severe left ventricular dysfunction or advanced heart failure (ejection fraction <30%)
  • Inability to maintain intraoperative arterial cannulation due to technical or clinical reasons
  • Inability to provide informed consent (e.g., cognitive impairment or refusal to participate)

结局指标

主要结局

Intraoperative hypotension endotype classification (hemodynamic subtype) per hypotension episode

时间窗: Intraoperative period (from anesthesia induction to the end of surgery)

For each intraoperative hypotension episode (defined as mean arterial pressure \[MAP\] \<65 mmHg lasting ≥1 minute, or a ≥30% decrease from baseline), the episode will be assigned to a hemodynamic endotype based on invasive arterial waveform-derived parameters recorded using MostCare® (Vygon, France), including MAP, SAP, DAP, HR, CO, CI, SV, SVI, SVR, SVRI, SVV, PPV, and SPV, sampled every 30 seconds. The outcome is the endotype label assigned to each episode, reported as a categorical classification with the following levels: Hypovolemic endotype, Vasodilatory endotype, Myocardial depression endotype and Bradycardic endotype.

次要结局

  • Time to hemodynamic stabilization after treatment of intraoperative hypotension(Intraoperative period (from anesthesia induction to the end of surgery))
  • Correlation between patient characteristics and intraoperative hypotension burden(Intraoperative period (from anesthesia induction to the end of surgery))
  • Performance of AI-based personalized hypotension treatment recommendation model(Intraoperative period (from anesthesia induction to the end of surgery))

研究者

发起方
Nevsehir Public Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mehmet Akif Yazar, MD

Associate Professor

Nevsehir Public Hospital

研究点 (1)

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