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临床试验/NCT00500981
NCT00500981已完成1 期

Do Internal Jugular Vein Measurements Made By Ultrasound Correlate With Fluid Responsiveness in Ventilated Post-Operative Cardiac Surgical Patients?

University of Calgary2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
To evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients.

研究概览

简要总结

The goal of this study is to evaluate whether measures of the size of the internal jugular vein have clinical utility in predicting whether patients may benefit from treatment with intravenous fluid.

详细描述

The optimal therapy for numerous disease states involves the replenishment of intravascular volume. Unfortunately, our current clinical measures of volume status are imperfect. Given biologic plausibility and preliminary study, it is possible that static and/or dynamic measures of internal jugular vein (IJV) size may correlate with volume status and/or be associated with volume responsiveness. If so, this type of assessment might be a more ideal clinical volume-assessment tool. This pilot study aims to establish proof of concept via evaluation of this question in patients following cardiac surgery.

This is a prospective observational study of physiologically-stable, ventilated patients post-cardiac surgery. The primary objective of this study is to evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients. A secondary objective is to evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in the same group. Static and dynamic ultrasound measurements of the right IJV will be performed pre-volume challenge.

Volume responsiveness will be independently assessed by cardiac index measurement before and after rapid infusion of 10% pentastarch. 30 subjects will be recruited pre-operatively and informed consent obtained. Stability of sedation, mechanical ventilation, and hemodynamics will be assured prior to initiation of measurements. Baseline static and respiratory dynamic ultrasound measurements of the right IJV will be obtained and then repeated after bilateral leg-raising. Baseline hemodynamics and cardiac outputs will be obtained using indwelling pulmonary artery catheters. A standardized volume challenge of 10% pentastarch given over 15 minutes will then be provided followed by repeat hemodynamic and cardiac output measurements.

Offline measurements of IJV size will be obtained from unmodified stored video loops by a single observer blinded to patient identity, hemodynamic, and fluid response data. Fluid responsiveness will be assessed by examining the change in cardiac index after volume challenge with a fluid responsive state defined as an increase of ≥ 12 % of cardiac index after volume challenge. The relationship between volume responsiveness and IJ ultrasound measures will be evaluated continuously and dichotomously.

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
Single (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

  • Adults (>18 years old)
  • Able to provide advanced informed consent
  • Planned elective or semi-urgent cardiac surgery

排除标准

  • Severe tricuspid regurgitation or planned tricuspid valve surgery
  • Congenital heart disease associated with cardiac shunting
  • Pre or post-operative presence of an intra-aortic balloon pump
  • Severe chronic obstructive pulmonary disease
  • Hemodynamic instability such that inotropes/vasopressor dosing is not constant
  • Respiratory instability and/or need for PEEP > 5 cmH20

结局指标

主要结局

To evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients.

时间窗: 1 hour

次要结局

  • To evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in ventilated post-operative cardiac surgical patients.(1 hour)

研究者

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

Dr. Dan Zuege

Clinical Associate Professor of Medicine

University of Calgary

研究点 (2)

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