跳至主要内容
临床试验/NCT04913493
NCT04913493终止不适用

Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital Length of Stay: a Prospective Cohort Study

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
Number of hospitalisation days. (LOS)

研究概览

简要总结

the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone.

The FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • •Age ≥ 18 years
  • •Males and females
  • •ASA III classification
  • •Written informed consent obtained by the patient
  • •Elective hospital admission for major vascular surgery procedures (CEA, open AAA, EVAR, TEVAR, FEVAR)

排除标准

  • •Age < 18 years
  • •Presence of permanent cardiac arrythmias
  • •Weight < 55kg and > 140kg
  • •Pregnancy
  • •Emergency surgery
  • •Minor vascular procedures
  • •Refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)

研究组 & 干预措施

Control group

No Intervention

Patients will only receive FloTrac/Vigileo monitoring which is standard of care.

Experimental group

Experimental

Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.

干预措施: Cytocam-IDF (Procedure)

结局指标

主要结局

Number of hospitalisation days. (LOS)

时间窗: up to 30 Days

How long is the hospital Length-Of-Stay?

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 (2)

Loading locations...

相似试验