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临床试验/NCT06188039
NCT06188039已完成不适用

Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry (PRESCIENCE)

Uniwersytecki Szpital Kliniczny w Opolu1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月3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
发起方
入组人数
150
试验地点
1
主要终点
Fluid responsiveness

研究概览

简要总结

The goal of this prospective study is to validate the superior vena cava collapsibility index (SVC-CI) as a predictor of fluid responsiveness during laparotomy and open aortic surgery. The SVC-CI and patients' response to fluid will be assessed based on transesophageal echocardiography.

The study has three arms, in order to validate SVC-CI under the conditions of laparotomy, aortic cross clamping and high PEEP levels. One of the study arms will be an active comparator arm.

The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner, in order to decrease perioperative mortality.

详细描述

Patients undergoing high-risk non-cardiac surgery, including acute laparotomies and open aortic surgery, are at high risk of postoperative complications and adverse cardiovascular events. Perioperative fluid therapy is a factor which is strongly associated with postoperative outcomes. To avoid both hypovolemia and excessive fluid administration a strategy of goal-directed fluid therapy (GDFT) has been coined. Traditionally in the setting of operating rooms GDFT relied on stroke-volume variation (SVV) measured by hemodynamic monitors, based on uncalibrated pulse contour cardiac output analysis (uAPCO). However in the described cohort of patients uAPCO methods show a significantly increased measurement error, which is mainly attributed to dynamic changes in peripheral vascular tone. Furthermore, frequent occurrence of arhytmias in those patients limits the use of SVV and all other dynamic indices of fluid responsiveness based on those methods. Superior vena cava collapsibility index (SVC-CI) is a parameter which is devoid of the above mentioned limitations. It relies on respiratory variation of superior vena cava during the respiratory cycle and is therefore reliable in patients with irregular heart rhytm and seems independent from changing afterload conditions.

The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery, with focus on elevated PEEP levels and aortic cross-clamping.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Signed ICF (informed consent form)
  • Age > 18 years old Eligibility criteria for each arm (additionally to mandatory criteria)
  • Arm 1 - Patients undergoing open aortic surgery
  • Arm 2 - Patients undergoing laparotomy
  • Arm 3 - Patients undergoing laparotomy with sinus rhytm

排除标准

  • Patients who are deemed to be at risk of harm due to excessive fluid administration:
  • End-stage renal disease (eGFR <15ml/kg/min)
  • Decompensated heart failure
  • Respiratory failure prior to surgery
  • Other cases where the risk of harm from fluid overload is assessed to be significant by the investigator
  • Medical contraindication to the use of transesophageal echocardiography:
  • Active ulcerative gastritis or bleeding from upper gastrointestinal tract
  • Past history of esophageal or gastric surgery
  • Esophageal varices or other esophageal disease (stricture, Barret's disease, perforation in the past, achalasia)

研究组 & 干预措施

Patients undergoing open aortic surgery with sinus rhythm

Experimental

Arm to validate SVC-CI during open aortic surgery with special focus of predicting FR during aortic cross clamping (n=50).

干预措施: Superior vena cava collapsibility index (Diagnostic Test)

Patients undergoing laparotomy and high PEEP

Experimental

Arm designed to validate SVC-CI during laparotomy, ventilated with high PEEP levels (8-10cmH2O). PEEP will be raised transiently during measurements (n=50).

干预措施: Superior vena cava collapsibility index (Diagnostic Test)

Patients undergoing laparotomy and high PEEP

Experimental

Arm designed to validate SVC-CI during laparotomy, ventilated with high PEEP levels (8-10cmH2O). PEEP will be raised transiently during measurements (n=50).

干预措施: PEEP elevation (Other)

Patients undergoing laparotomy with standard ventilatory settings

Active Comparator

Arm designed as an active comparator with standard (protective) ventilatory settings (n=50). Tidal volumes (Vt) will be set for 8ml/kg.

干预措施: Superior vena cava collapsibility index (Diagnostic Test)

结局指标

主要结局

Fluid responsiveness

时间窗: Directly after infusing fluid bolus.

Fluid responsiveness was defined as an increase of 10% or more of cardiac output (CO) following an administered 250ml fluid bolus. Changes in CO will be estimated using changes in left ventricle outflow tract velocity time integral (LVOT-VTI) assessed by transesophageal echocardiography to avoid errors associated with measuring LVOT area, which is necessary to calculate CO.

次要结局

未报告次要终点

研究者

发起方
Uniwersytecki Szpital Kliniczny w Opolu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Królicki, MD PhD

Principal Investigator

Uniwersytecki Szpital Kliniczny w Opolu

研究点 (1)

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