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临床试验/NCT03508401
NCT03508401Unknown不适用

Transthoracic Echocardiographic Assessment of the Superior Vena Cava Flow Respiratory Variation in ICU Intubated Patients

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2018年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
188
试验地点
1
主要终点
ventricular outflow tract velocity time index (LVOT TVI)

研究概览

简要总结

Acute circulatory failure is frequent, affecting up to one-third of patients admitted to intensive care units (ICU). Monitoring hemodynamics and cardiac function is therefore a major concern. Analysis of respiratory diameter variations of the superior vena cava (SVC) is easily obtained with transesophageal echocardiography (TEE) and is helpful to assess fluid responsiveness.

Transthoracic echocardiography (TTE) exploration of the SVC is not used in routine. Recently, micro-convex ultrasound transducers have been marketed and these may be of use for non-invasive SVC flow examination. However, analysis of diameter variations of the SVC with TTE does not seem to be possible since the approach from the supraclavicular fossa does not allow for a good visualization of the SVC walls.

It was recently demonstrated in a short pilot study that TTE examination of the SVC flow with a micro-convex ultrasound transducer (GE 8C-RS) seems both easy to learn and to use (feasibility = 84.9%), and is reproducible in most ventilated ICU patients with an intraclass correlation coefficient for the systolic fraction of the superior vena cava flow of 0.90 (95% confidence interval [0.86-0.93]).

The hypothesis is that cardio-respiratory interactions in intubated-ventilated patients are responsible of SVC flow variations and that the analysis of the SVC flow respiratory variations could be a new predictive tool of fluid responsiveness.

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
否

入选标准

  • •Adult patients (≥ 18 years old)
  • •Admission in ICU after tracheal intubation or tracheal intubation during the ICU stay
  • •Volume-controlled ventilation with a tidal volume of 8 mL/kg
  • •Patient or family agreement for the inclusion

排除标准

  • •Persistence of spontaneous breathing
  • •Cardiac arrhythmia
  • •Severe Acute Respiratory Distress Syndrome, defined as PaO2/FIO2 ratio < 100
  • •Acute right ventricular failure defined by S'VD < 10 cm or Tricuspid Annular Plane Systolic Excursion (TAPSE) < 10 mm measured with Transthoracic Echocardiography (TTE)

研究组 & 干预措施

ICU intubated patients

Experimental

After inclusion, Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). The left ventricular outflow tract velocity time index (LVOT TVI) will be measured with this device. Then, a passive leg raising (PLR) will be performed and finally LVOT VTI will be measured again after PLR

Patients will be classified in two groups according to the hemodynamic response to PLR :

  • Patients are responders if LVOT VTI increases of at least 10% after PLR
  • patients are non-responders if LVOT VTI does not increase or increase of less than 10% after PLR.

干预措施: Passive leg raising (PLR) (Other)

ICU intubated patients

Experimental

After inclusion, Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). The left ventricular outflow tract velocity time index (LVOT TVI) will be measured with this device. Then, a passive leg raising (PLR) will be performed and finally LVOT VTI will be measured again after PLR

Patients will be classified in two groups according to the hemodynamic response to PLR :

  • Patients are responders if LVOT VTI increases of at least 10% after PLR
  • patients are non-responders if LVOT VTI does not increase or increase of less than 10% after PLR.

干预措施: Echo-Doppler measurements (Device)

结局指标

主要结局

ventricular outflow tract velocity time index (LVOT TVI)

时间窗: The day of inclusion

Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). All measurements are recorded at the end of expiration. Echo-Doppler measurements are performed in the upper part of the SVC, approximately 1 to 2 cm below the brachiocephalic vein. From this view, pulse Doppler is performed. Pulse Doppler waves obtained in the SVC are used to obtain velocity time integrals (VTI). Expiratory VTI is named VTImax and inspiratory VTI is named VTImin. These values will allow the calculation of Respiratory variations of the superior vena cava flow (ΔSVCf). ΔSVCf is calculated as(VTImax- VTImin )/(1/2(VTImax+ VTImin))

次要结局

  • optimal cut-off value of ΔSVCf to predict fluid-responsiveness(The day of inclusion)
  • proportion of patients in which measurement of ΔSVCf is not possible(The day of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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