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临床试验/NCT02063009
NCT02063009已完成不适用

Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery

Gustave Roussy, Cancer Campus, Grand Paris1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Estimation of the reliability of the measurement of the variations of the CI during fluid challenge

研究概览

简要总结

Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

详细描述

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. We conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • presence of port
  • scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
  • oral consent of the patient after oral and written information

排除标准

  • age inferior to 18
  • Contraindication or failure to the insertion of the CVC
  • Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow

结局指标

主要结局

Estimation of the reliability of the measurement of the variations of the CI during fluid challenge

时间窗: measurement of the CI hourly, up to 3 hours by TPTD before and after fluid challenge via the port versus the CVC.

Measurements will be realized as described: * hourly: TPTD will be realized to calibrate the measurement of CI * Before and after fluid challenge (250 ml of colloid when hemodynamic indicators will be in favour of hypovolemia (pulse pressure variation (PPV) \> 15% and variation of CI \> 10%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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