跳至主要内容
临床试验/NCT05254951
NCT05254951已完成不适用

Tidal Volume Challenge to Assess Volume Responsiveness with Dynamic Preload Indices During Surgery: a Prospective Study

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Delta (Δ)SVV(T2-T1)

研究概览

简要总结

The purpose of this study is to investigate the ability of changes in PPV and SVV after Tidal Volume Challenge to predict fluid responsiveness in patients undergoing general anesthesia with protective mechanical ventilation.

详细描述

Intraoperative algorithms and protocols regarding fluid therapy are key factors to prevent perioperative hypovolaemia or hypervolaemia, which are both known to increase morbidity and length of hospital stay. Response to fluid therapy (increase in stroke volume, SV) after a bolus infusion should be based on predictors of fluid responsiveness. It has been shown previously that static indices, such as central venous pressure or pulmonary wedge pressure are unsuitable for this purpose. Conversely dynamic indices such as stroke volume variation (SVV) or pulse pressure variation (PPV), can reliably predict fluid responsiveness during mechanical ventilation with a tidal volume of at least 8 ml/kg.

In recent years, the use of lung-protective ventilation strategy with tidal volumes of less than 8 ml/kg (e.g. Vt = 6ml/kg of ideal body weight) has been associated with better outcome of patients9 and has been recommended as the standard intraoperative mechanical ventilation strategy.10 Reduced tidal volumes, however, limit the reliability of dynamic PPV and SVV indicators. In order to overcome this Vt-related limitation to PPV and SVV, functional hemodynamic tests should be applied,11 aimed at increasing right ventricle preload. For example, discontinuation of mechanical ventilation as in the end-expiratory occlusion test (EEOT) has been tested, in intensive care patients, as well as in a surgical polulation with conflicting results.15,16 Recently Myantra and coll tested the tidal volume challenge (VtC) in 20 severely ill patients with acute circulatory failure. They demonstrated that the response to fluid administration can be reliably predicted through changes in PPV and SVV after VtC, defined as an increase in Vt to 8 ml/kg for 1 minute.

Tidal volume challenge has also been successfully tested in surgical patients. In neurosurgical patients in both supine and prone position. Messina and coll demonstrated that VtC can predict the response to fluid administration through a change in PPV and SVV with high sensitivity and specificity. In robotic laparoscopic procedures in the Trendelenburg position, Jun and coll20 showed PPV changes after a VtC were more sensitive and specific in predicting fluid responsiveness than SVV changes.

The purpose of this study is to investigate the ability of changes in PPV and SVV after VtC to predict fluid responsiveness in patients undergoing general anesthesia with protective mechanical ventilation.

Patient population / study design

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patients over 18 years of age
  • General surgery or Vascular surgery patients without clamping of the aorta.
  • Will require arterial cannulation and invasive blood pressure monitoring during surgery
  • The expected duration of the operation will be equal to or greater than 90 minutes

排除标准

  • preoperative arrhythmia or newly emergent arrhythmia after anesthesia induction
  • Reduced left (EF < 40%) or right systolic function
  • Preoperative use of beta-blockers
  • Chronic obstructive pulmonary disease with FEV1 <60% predicted volume

结局指标

主要结局

Delta (Δ)SVV(T2-T1)

时间窗: intraoperative, one hour and 3 minutes after anesthesia induction

the difference between SVVT2 and SVVT1

Delta(Δ) PPV(T2-T1)

时间窗: intraoperative, one hour and 3 minutes after anesthesia induction

the difference between PPVT2 and PPVT1

次要结局

  • SVI(intraoperative, 60, 63, 68 and 78 minutes after anesthesia induction)
  • PPVT3(intraoperative, one hour and 8 minutes after anesthesia induction)
  • PPVT4(intraoperative, one hour and 18 minutes after anesthesia induction)
  • SVVT4(intraoperative, one hour and 18 minutes after anesthesia induction)
  • Delta (Δ) PPVT4-T3(intraoperative, one hour and 18 minutes after anesthesia induction)
  • PPVT1(intraoperative, one hour after anesthesia induction)
  • SVVT2(intraoperative, one hour and 3 minutes after anesthesia induction)
  • PPVT2(intraoperative, one hour and 3 minutes after anesthesia induction)
  • SVVT3(intraoperative, one hour and 8 minutes after anesthesia induction)
  • Delta (Δ) SVVT4-T3(intraoperative, one hour and 18 minutes after anesthesia induction)
  • SVVT1(intraoperative, one hour after anesthesia induction)
  • HPI(intraoperative, 60, 63, 68 and 78 minutes after anesthesia induction)
  • MAP(intraoperative, 60, 63, 68 and 78 minutes after anesthesia induction)
  • Cdyn(intraoperative, 60, 63, 68 and 78 minutes after anesthesia induction)

研究者

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

Tatiana Sidiropoulou

Associate Professor of Anesthesiology

Attikon Hospital

研究点 (2)

Loading locations...

相似试验