跳至主要内容
临床试验/NCT03612687
NCT03612687已完成不适用

Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年5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
20
试验地点
1
主要终点
Incidence of intraoperative complications

研究概览

简要总结

This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.

详细描述

Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.

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

  • Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.

排除标准

  • Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas
  • Suspected inability to comply with trial procedures or understand consent
  • Employee at the investigational center, relative or spouse of the investigators
  • Patients incarcerated at the time of surgery
  • Females who are pregnant or breastfeeding
  • Planned use of Cell Saver during surgical procedure

结局指标

主要结局

Incidence of intraoperative complications

时间窗: Intraoperative period

Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events

次要结局

  • Extubation time(up to 48 hours)
  • Length of hospital stay(up to 10 days)
  • Incidence of postoperative blood transfusions(up to 10 days)
  • Incidence of postoperative complications(up to 10 days)
  • ICU length of stay(up to 3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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