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临床试验/NCT05354661
NCT05354661已完成不适用

Non-Invasive Hemodynamic Monitoring and Incidence of Perioperative Hypotension in Gynaecologic Oncologic Surgery: Hypotension Prediction Index Working With ClearSight Versus Arterial Waveform Analysis Alone

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Cumulative Intraoperative Hypotension

研究概览

简要总结

Background Intraoperative hypotension is associated with increased morbidity and mortality. The Hypotension Prediction Index (HPI) is an advancement of the arterial waveform analysis to predict intraoperative hypotension minutes before episodes occur enabling preventive treatments.

This study will test the hypothesis that a hemodynamic treatment protocol based on HPI working with non-invasive ClearSight system reduces intraoperative hypotension when compared to standard goal directed therapy (GDT) in patients undergoing gynaecologic oncologic surgery.

Methods A retrospective analysis of 68 adult consecutive patients undergoing gynaecologic oncologic surgery with non-invasive arterial pressure monitoring using either index guidance (HPI) or classic ClearSight system waveform analysis depending on availability (ClearSight, n = 36; HPI, n = 32) will be conducted. A hemodynamic GDT protocol was applied in both groups. The primary endpoint will be the incidence and duration of hypotensive events defined as MAP <65 mmHg evaluated by time-weighted average of hypotension.

详细描述

INTRODUCTION Intraoperative hypotension (IOH) is a common adverse event during noncardiac surgery [1,2]. It is associated with an increased incidence of acute kidney injury, myocardial injury, neurological deficiencies, as well as an increased 30-day operative mortality [3-7]. Organ injuries were shown to be associated with the depth, frequency, and duration of hypotensive episodes [4,8]. Data indicate that a mean arterial pressure of 65 mmHg serves as a threshold to predict myocardial and kidney injury [9-11].

Recently developed minimally invasive methods of the arterial waveform analysis allow calculation of cardiac output, stroke volume, stroke volume variation, and systemic vascular resistance. This deeper insight into hemodynamics enables goal-directed therapy approaches; however, the given information only allows to react to events instead of preventing them [12,13].

Interestingly, recent data indicate a significant reduction in postoperative organ dysfunction by preventing IOH, suggesting a potential benefit of early intervention [14].

Surgical interventions for cancer mass reduction are among the most invasive operations in gynaecology. Extensive surgical trauma results in severe intra- and perioperative volume shifts and unstable hemodynamics [15]. Major abdomino-pelvic surgery for gynaecological oncologic surgery (GOS) may include hysterectomy, oophorectomy, omentectomy, colectomy, removal of the lymph nodes and peritoneal stripping. Surgery is carried out through laparoscopy or a laparotomic incision and is often associated with significant blood loss [16]. Hypotension during GOS is common, and as it is associated with the potential for harm, it requires prompt evaluation and treatment [16]. Extensive fluid resuscitation in peritoneal cancer patients is associated with a poor postoperative outcome independent from the underlying malignant disease and avoiding fluid overload is recommended [15].

Therefore, the prediction of intraoperative hypotension and consequently its prevention by proactive treatment may show beneficial effects for patients. Machine learning, a discipline within computer science used to analyse large data sets and to develop predictive models, has evident applications in health care [17,18]. Several attempts to use algorithms as an aid in anaesthesiology practice recently received renewed attention, with the aim of optimizing patients' perioperative status, primarily focusing on detection of early hemodynamic instability and prediction of hypotension [19].

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Gynecologic Oncologic surgery procedures

排除标准

  • Severe valvulopathy
  • Cardiac failure
  • Severe aortic stenosis
  • Severe cardiac arrhythmias
  • Coagulopathy
  • Contraindication to arterial calculation
  • Patient's refusal

结局指标

主要结局

Cumulative Intraoperative Hypotension

时间窗: At the end of surgery

Comparison, in the two groups, of the amount of intraoperative hypotension (MAP \< 65 mmHg), measured with TWAMAP method.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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