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临床试验/NCT04547491
NCT04547491已完成不适用

Hemodynamic Monitoring and Prediction of Hypotension Through the HPI Algorithm During Major Gynecologic Oncologic Surgery: a Randomized Controlled Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Cumulative Intraoperative Hypotension

研究概览

简要总结

Intraoperative hypotension (IOH) is a rather common event during general surgery, with variable incidence that ranges between 5 and 99% based on the definition used. It is associated to significant complications including acute renal failure, myocardial damage, stroke and overall increased mortality, reason why the prevention and the reduction of hypotensive events through an appropriate proactive approach can potentially improve the patient's outcome. The Hypotension Prediction Index (HPI) is an algorithm derived from the analysis of the arterial waveform and it is expressed as an absolute value from 0 to 100. It has been demonstrated that the HPI is able to predict the occurrence of hypotensive events of patients undergoing major surgery under general anesthesia, providing also a guide for the appropriate treatment based on further calculated secondary hemodynamic variables that estimate patient's preload, cardiac contractility and afterload. Aim of this prospective randomized study is to compare the incidence of IOH during major gynecologic oncologic surgery among two groups of patients receiving standard hemodynamic monitoring versus HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of intraoperative hypotensive events, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute.

详细描述

Intraoperative hypotension (IOH) represents a common event during general anesthesia (GA), with an estimated incidence between 5% and 99%, according to definition adopted [1].

Actually, a mean arterial pressure (MAP) below 65 mmHg is considered an appropriate definition of IOH [2].

Hypotension mainly occurs during anaesthesia due to three pathophysiological dysregulations: hypovolemia and consecutively decreased cardiac output, myocardial depression and low systemic vascular resistance [3]. IOH has been associated with postoperative acute acute kidney injury and myocardial injury; it seems that the cumulative time spent in hypotension increases the risk, and this has implications as even relatively short episodes of hypotension that are treated promptly can over time reach accumulated hypotension time associated with increased injury rates [4-7]. Therefore, anaesthetic management that aims to prevent IOH using a "pro-active" treatment protocol might potentially reduce the amount and severity of IOH, perioperative complications and mortality. In order to detect and treat these haemodynamic alterations, advanced haemodynamic monitoring combined with a treatment algorithm can be used [8].

The Hypotension Prediction Index (HPI) algorithm was recently established by Edwards Lifesciences (Irvine, USA). Based on the Edward´s monitoring platform (HemoSphere), HPI is a monitoring tool which aims to predict IOH up to 15 min before its onset [9, 10]. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the risk of an event occurring in the future increases. The HPI was developed using machine learning methods and is a data-driven model developed from over 200,000 hypotensive patient events and it predicts upcoming hypotensive events based on features of the arterial pressure waveform [9].

When HPI rises over 85, the monitor Hemosphere provides a secondary screen showing the following hemodynamic parameters: stroke volume variation (SVV) as indicator of fluid responsiveness - preload, radial dP/dtmax as indicator of cardiac contractility, and dynamic elastance (Eadyn) as dynamic indicator of resistance - afterload. Hemodynamic variables, hemodynamic diagnostic guidance and the definition of a treatment protocol, should allow for determination and treatment of the underlying cause of the impending hypotension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Major Gynecologic Oncologic surgery procedures (expected duration > 2 hours)

排除标准

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

研究组 & 干预措施

GDT group

Other

Cardiac optimization with goal-directed therapy, liberal use of vasopressor agents.

干预措施: GDT (Device)

HPI group

Experimental

Hemodynamic management HPI-based, protocol-based use of fluids, vasopressors and inotropes.

干预措施: HPI - hypotension prediction index (Device)

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 TWA-MAP method.

次要结局

  • Adverse events(At 7 days after surgery.)
  • Hypotension after anesthesia induction(20 minutes after anesthesia induction)
  • Severe hypotension(At the end of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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