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临床试验/NCT05884918
NCT05884918招募中不适用

Risk Factors and Frequency of Intraoperative Hypotension in High-risk Patients Undergoing Surgery: A Multicenter Observational Prospective Study

Mazovia Regional Hospital in Siedlce1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Incidence of intraoperative hypotension (IOH)

研究概览

简要总结

The primary objective of this observational study is to investigate the risk factors for intraoperative hypotension and identify the underlying pathomechanisms leading to it, both during the period after general anesthesia induction and throughout its course.

The main questions it aims to answer are:

  • how frequent is intraoperative hypotension
  • what are the underlying pathomechanism causing it The study is including patients who have been identified as having a high risk of perioperative complications (ASA3 or ASA4). Patients included in the study undergo advanced hemodynamic monitoring during the procedure. Anesthesia induction, maintenance, and termination are conducted by an anesthesiologist in accordance with current medical knowledge, and the planned experiment does not in any way influence the course of action.

Investigators will analyse medical documentation, including the patient's medical history, anesthesia records, and hemodynamic parameter data obtained from the hemodynamic monitor (an Excel file containing comprehensive data related to specific cardiovascular parameters) to describe the incidence of intraoperative hypotension and answer key questions in accordance with the designed study protocol.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age >18 years old.
  • Capability of providing informed consent by the patient.
  • Planned surgeries.
  • Surgeries other than thoracic, cardiac, or obstetric procedures.
  • ASA (American Society of Anesthesiologists) physical status classification of 3 or 4, indicating high risk.
  • Patients at high risk of postoperative complications.
  • Preoperative qualification for advanced hemodynamic monitoring.
  • Access to complete preoperative health status data.
  • Access to complete data regarding the course of anesthesia and hemodynamic parameters obtained from the hemodynamic monitoring platform.
  • Initiation of hemodynamic monitoring prior to general anesthesia induction.

排除标准

  • Age <18 years old.
  • Cardiac surgeries.
  • Thoracic surgeries.
  • Obstetric procedures.
  • Inability of the patient to provide informed consent.
  • ASA physical status classification of 1, 2, or 5, indicating low or moderate risk.
  • Urgent and emergent surgeries.
  • Lack of complete preoperative health status data.
  • Lack of complete data regarding the course of anesthesia.
  • Inability to initiate hemodynamic monitoring prior to general anesthesia induction.
  • Interruption in hemodynamic monitoring lasting longer than 5 minutes (lack of parameter values in the obtained hemodynamic monitor file).

结局指标

主要结局

Incidence of intraoperative hypotension (IOH)

时间窗: Intraoperative

Incidence of IOH due to the general anesthesia

Risk factors of IOH.

时间窗: Perioperative

Rate of specific clinical and demographical parameters associated with IOH

次要结局

  • Determination of indications for intraoperative extended hemodynamic monitoring.(Perioperative)
  • Development of a risk scale for IOH (MAP < 65mmHg) based on the identified risk factors in the study.(Perioperative)
  • Assessment of the incidence, duration, and depth of hypotension as a complication of general anesthesia at each stage of anesthesia.(Perioperative)
  • Evaluation of the relationship between the depth and duration of hypotensive episodes and the occurrence of postoperative complications within 30 days of the surgical procedure.(Perioperative to 30 days after surgery)
  • Analysis of the anesthesiologist's management approach in the event of hypotensive episodes or hypotension risks and an attempt to establish an optimal management strategy for its occurrence.(Perioperative)

研究者

发起方
Mazovia Regional Hospital in Siedlce
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jolanta Cylwik

Principal Investigator

Mazovia Regional Hospital in Siedlce

研究点 (1)

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