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临床试验/NCT03493074
NCT03493074Unknown不适用

Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Pulse wave change from baseline during EVAR measured by a force sensor

研究概览

简要总结

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

详细描述

Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient has been clinically examined at policlinic of vascular surgery
  • The patient has been examined with computed tomography (CT) imaging
  • The patient has been considered a candidate for the EVAR of the AAA

排除标准

  • A patient has a pacemaker
  • A medical doctor decides that the measurement disturbs or risks the subject's treatment process
  • Subject's denial (or withdrawal)
  • A patient has at least one amputated limb
  • The age of the test subject candidate is less than 18 years
  • A test subject candidate is not able to understand the study or is not legally competent
  • A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome

结局指标

主要结局

Pulse wave change from baseline during EVAR measured by a force sensor

时间窗: 2 hours

A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave

Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor

时间窗: 2 hours

Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements

次要结局

  • Pulse wave change from baseline after EVAR measured by a optical(12 months)
  • Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor(30 days)
  • Pulse wave change from baseline after EVAR measured by a force sensor(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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