此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2021年11月9日 更新者:Denis SCHMARTZ、Brugmann University Hospital

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.

研究概览

详细说明

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.

At the present state, there are many different methods of interpreting intravascular circulating blood volume: those related to pressures measurements: the central venous pressure (CVP), the pulmonary artery occluded pressure (PAOP), and those related to cardiac output measurements like thermodilution and pulse contour techniques. It is worth noting that all these are invasive methods that expose patients to a series of possible side effects such as: pneumothorax, infections, hematomas and vascular lesions. 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.

TTE is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows.

In particular, the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava (IVC) and its compliance, allowing the physician to obtain valuable information on the volume status of patients: several studies have reported that these measurements could predict accurately the hemodynamic response of patient to a change in cardiac preload. However, acquiring images in the subcostal window can be, in some cases, difficult or impossible due to the presence of drainages or surgical wounds; in such cases an alternative could be represented by the trans-hepatic window which, at the best of the investigator's knowledge, it has never been validated in the literature.

The Clear Sight System is a non-invasive blood pressure (BP) monitoring system, where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs.

Its main advantage is to assess CO continuously in a completely non-invasive way, following its variations and thereby contributing to the detection of hypovolaemia. Other visualized parameters are: the stroke volume (SV), the systemic vascular resistance (SVR) as well as the BP and the heart rate (HR).

Passive leg raising (PLR) is a test developed to predict patient's hemodynamic response to increase preload without any fluid administration. Raising the patient from a semi-recumbent position to a position with the head at 0° and the legs raised to a 45° angle is associated with about 300 ml of blood volume mobilization from the lower limbs and splanchnic territory to the central compartment resulting in increased venous return to the heart. This manoeuvre provokes a preload increase to which patients could respond with (responder) or without (non-responders) an augmentation of their cardiac output.

The aim of this study is to assess whether the measure of the 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.

研究类型

介入性

注册 (实际的)

53

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Brussels、比利时、1020
        • CHU Brugmann

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Surgery
All patients, who have given their consent, aged over 18 years, with a sinus rhythm, requiring a surgical procedure that allows obtaining high quality transthoracic echocardiogram imaging without pain and discomfort.
Transthoracic echocardiogram (TTE) is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows. In particular, the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava (IVC) and its compliance, allowing the physician to obtain valuable information on the volume status of patients. Acquiring images in the subcostal window with a transthoracic echocardiogram (TTE) can be, in some cases, difficult or impossible due to the presence of drainages or surgical wounds: in such cases an alternative could be represented by the trans-hepatic window. This has not been validated in the scientific litterature.

The Clear Sight System is a non-invasive blood pressure (BP) monitoring system, where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs.

Its main advantage is to assess CO continuously in a completely non-invasive way, following its variations and thereby contributing to the detection of hypovolaemia. Other visualized parameters are: the stroke volume (SV), the systemic vascular resistance (SVR) as well as the BP and the heart rate (HR).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Difference of sensitivity between the trans-hepatic window versus the subcostal window with TTE
大体时间: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.
20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with TTE
大体时间: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.
20 minutes

次要结果测量

结果测量
措施说明
大体时间
Difference of sensitivity between the trans-hepatic window versus the subcostal window with the Clear Sight system
大体时间:20 minutes
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
20 minutes
Difference of specificity between the trans-hepatic window versus the subcostal window with the Clear Sight system
大体时间:20 minutes
Comparison of the sensitivity and specificity of both the trans-hepatic window and the subcostal window to predict the cardiac output response (with the Clear Sight system) to passive leg raising.
20 minutes
Right atrial pressure (RA)- trans-hepatic window
大体时间:20 minutes
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
20 minutes
Right atrial pressure (RA) - subcostal window
大体时间:20 minutes
Evaluation of the estimation of RA pressure obtained with the trans-hepatic and sub-costal approaches
20 minutes
Cardiac output
大体时间:20 minutes
Cardiac output calculated by: CO= sub-Aortic Velocity Time Integral (sAoVTI) × heart rate in beats per minute (bpm) × left ventricular outflow track (LVOT)
20 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Francesco Zuccarini、CHU Brugmann

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月25日

初级完成 (实际的)

2021年10月30日

研究完成 (实际的)

2021年11月9日

研究注册日期

首次提交

2021年4月26日

首先提交符合 QC 标准的

2021年4月28日

首次发布 (实际的)

2021年4月29日

研究记录更新

最后更新发布 (实际的)

2021年11月10日

上次提交的符合 QC 标准的更新

2021年11月9日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CHUB-WICAVE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅