跳至主要内容
临床试验/NCT04866095
NCT04866095已完成不适用

Inferior Vena Cava Compliance in Trans-thoracic Echocardiography: is the Trans-hepatic Window as Reliable as the Subcostal One

Brugmann University Hospital2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年6月25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
53
试验地点
2
主要终点
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE

研究概览

简要总结

The ability to assess intravascular volume is an essential part of perioperative care: insufficient intravascular volume can result in decreased oxygen delivery to tissues and organ dysfunction, while fluid overload can contribute to the development of oedema, organ dysfunction, respiratory failure and healing defect.

At the present state, there are many different methods of interpreting intravascular circulating blood volume. Non-invasive techniques such as the Clear Sight System, and the transthoracic echocardiogram (TTE) have been proposed as non-invasive methods to assess patient' blood volume.

The aim of this study is to assess whether the measure of the inferior vena cava (IVC) in the trans-hepatic window is as reliable as in the subcostal window to determine fluid responsiveness in perioperative patients. In this study, preload increase will be obtained through passive leg raising. Sensibility and specificity of the two echocardiographic approaches to predict fluid responsiveness will be compared while using the subcostal window as the "gold standard". The effect of passive leg elevation on patient's cardiac output response will be assessed with two different non-invasive techniques: the Clear Sight system and the TTE.

详细描述

The ability to assess intravascular volume is an essential part of perioperative care: insufficient intravascular volume can result in decreased oxygen delivery to tissues and organ dysfunction, while fluid overload can contribute to the development of oedema, organ dysfunction, respiratory failure and healing defect.

Assessment of the volume status in perioperative patients relies on two important concepts: euvolemia and fluid responsiveness.

Euvolemia describes a state of adequate circulating blood volume that allows suitable filling of the cardiac chambers making possible for the heart to produce a cardiac output that meets the peripheral oxygen demand.

Fluid responsiveness describes the ability of the heart to adapt blood flow in response to preload increase.

As euvolemia is the ultimate goal of fluid administration then evaluating fluid responsiveness reflects the process of working toward establishing euvolemia.

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

  • All patients of the CHU Brugmann hospital, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality TTE imaging without pain and discomfort.
  • Examples of such surgeries are:
  • Orthopaedic surgery: interventions of upper limbs.
  • Stomatology: dental extractions
  • Gastroenterology: oesophagus gastroscopy
  • Maxillo-facial surgery: septoplasties, rhinoplasties, Le Fort surgeries
  • ENT surgery: thyroidectomy, sleep endoscopies
  • Gynaecology: hysteroscopy, voluntary terminations of pregnancy
  • Ophthalmic surgery

排除标准

  • Refusal to participate to the study
  • suboptimal image acquisition
  • atrial fibrillation, patients with 6 or more extra systoles per minute
  • cardiac valvular pathologies
  • TTE imaging causing pain and/or discomfort to the patient
  • surgeries that don't allow obtaining high quality imaging, elevated intra-abdominal pressure.

结局指标

主要结局

Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE

时间窗: 20 minutes

Comparison of the sensitivity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.

Difference of specificity between the trans-hepatic window versus the subcostal window with TTE

时间窗: 20 minutes

Comparison of the specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response by transthoracic echocardiogram (TTE) to passive leg raising.

次要结局

  • Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system(20 minutes)
  • Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system(20 minutes)
  • Right atrial pressure (RA)- trans-hepatic window(20 minutes)
  • Right atrial pressure (RA) - subcostal window(20 minutes)
  • Cardiac output(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis SCHMARTZ

Head of anesthesiology department

Brugmann University Hospital

研究点 (2)

Loading locations...

相似试验

Inferior Vena Cava Compliance in Trans-thoracic... | 临床试验