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临床试验/NCT02292888
NCT02292888Unknown早期 1 期

Can Changes in LVOT VTI Before and After Passive Leg Raising (PLR) Test Serve as a Sensitive Indicator for Changes in SV and CO and Hence Volume Responsiveness ?

Fortis Hospital, India0 个研究点目标入组 50 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
50
主要终点
Whether a change in Doppler VTI before and after passive leg raising test (PLR) correctly reflects changes in stroke volume measured by CCO PA catheter

研究概览

简要总结

Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ).

The LVOT diameter for an individual is more or less a constant measurement. Therefore using the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this assumption is true, then an increase in the value of VTI from baseline after fluid challenge (10-15%), should identify a volume responsive patient.

详细描述

Can changes in LVOT VTI before and after passive leg raising (PLR) test serve as a sensitive indicator for changes in SV and CO and hence volume responsiveness ?

What is Doppler LVOT VTI? Placing a Pulsed Wave Doppler gate on the LVOT immediately below the opening of the aortic valve while aligning the Doppler beam as parallel to the LVOT/aortic axis as possible with an angle of Doppler alignment <20˚, one may obtain Doppler flow velocity measurements which can help measure the LVOT VTI (Velocity Time Integral). If one integrates this velocity profile between two time points (i.e., calculates the area under the curve), the distance traversed of "a region of blood" flowing during this period may be estimated. Since flow velocity is not constant throughout a flow cycle, all of the flow velocities during the entire ejection period is integrated to measure "distance traversed" of this "region of blood." This integration of flow velocities in a given period of time is called the velocity-time integral (VTI)(1) and yields length or distance (measured in cm).

Goal: Whether VTI (LVOT) measured from the deep transgastric (deep TG) or transgastric long axis (TG LAX ) views reflect changes in stroke volume(SV) and hence cardiac output (CO) measured by the gold standard method (PA CCO by thermodilution) before and after passive leg raising test (PLR).

Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ).

The LVOT diameter for an individual is more or less a constant measurement. Therefore using the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this assumption is true, then an increase in the value of VTI from baseline after fluid challenge (10-15%), should identify a volume responsive patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
Double (Care Provider, Outcomes Assessor)

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 undergoing CABG (coronary artery bypass surgery )

排除标准

  • Significant arrhythmias
  • Concomitant aortic aneurysms,
  • Esophageal pathology

研究组 & 干预措施

patients with LVEF >40%

Active Comparator

Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

干预措施: Passive Leg Raising (PLR) test (Other)

patients with LVEF < or equal to 40%

Active Comparator

Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

干预措施: Passive Leg Raising (PLR) test (Other)

结局指标

主要结局

Whether a change in Doppler VTI before and after passive leg raising test (PLR) correctly reflects changes in stroke volume measured by CCO PA catheter

时间窗: within 1 minute

the 3 highest values of VTI post PLR measured between 30 seconds to maximum of 60 seconds post PLR test are to be used and their mean value is to be compared with the mean stroke volume (SV) recorded by the CCO monitor during the same period.

次要结局

未报告次要终点

研究者

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

Saikat Bandyopadhyay, MD

Consultant Cardiac Anesthesiologist & Intensivist

Fortis Hospital, India

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